WO2014049566A2 - Nutritional kit - Google Patents

Nutritional kit Download PDF

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Publication number
WO2014049566A2
WO2014049566A2 PCT/IB2013/058945 IB2013058945W WO2014049566A2 WO 2014049566 A2 WO2014049566 A2 WO 2014049566A2 IB 2013058945 W IB2013058945 W IB 2013058945W WO 2014049566 A2 WO2014049566 A2 WO 2014049566A2
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WO
WIPO (PCT)
Prior art keywords
vitamin
kit
approximately
nutritional composition
nutritional
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PCT/IB2013/058945
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French (fr)
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WO2014049566A3 (en
Inventor
Susan Janse Van Rensburg
Winston BURSEY
Frans Johannes Cronje
Theresa JANSE VAN RENSBURG
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Stellenbosch University
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Publication of WO2014049566A2 publication Critical patent/WO2014049566A2/en
Publication of WO2014049566A3 publication Critical patent/WO2014049566A3/en
Priority to ZA2015/02635A priority Critical patent/ZA201502635B/en

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/175—Amino acids
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A23L33/155—Vitamins A or D
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula

Definitions

  • the present invention relates to a nutritional a kit for use in the treatment and management of demyelinating diseases.
  • Demyelinating diseases such as Multiple Sclerosis ("MS"), clinically isolated syndrome, psychiatric diseases such as depression and bipolar disorder, ADHD, mild cognitive impairment, developmental delay and peripheral demyelinating disorders are difficult to accurately diagnose and treat. Patients suffering from demyelinating diseases present with various clinical symptoms, which is illustrated well by MS.
  • MS Multiple Sclerosis
  • MS is a disorder in which autoreactive immune responses are involved in the attack on myelinated axons, causing lesions or scars in the insulating myelin sheth protecting axons. These lesions then interfere with the conduction of signals to the periphery.
  • the disease process is typically progressive and can lead to chronic disability.
  • the central nervous system is made up of nerves that act as the body's messenger system. Each nerve is covered by a fatty substance called myelin, which insulates the nerves and helps in the transmission of nerve impulses between the brain and other parts of the body. With demyelinating diseases such as MS, the myelin that protects the nerves is destroyed, causing scar tissue. This process is called demyelination. Without the myelin, electrical signals transmitted throughout the brain and spinal cord are disrupted or halted. The brain thus becomes unable to send and receive messages, causing a multitude of symptoms.
  • Myelin regeneration is a prerequisite for remission and various nutrients, such as iron, essential amino acids, lipids, vitamins and minerals play an important role in the regeneration of myelin.
  • Suitable treatment of demyelinating diseases depends largely on the type of demyelinating disease that the patient suffers from and the symptoms that a patient presents with. In the case of acute attacks, patients must often be hospitalised. Furthermore, the routine therapy for acute relapses typically includes the administration of high doses of intravenous corticosteroids. Although corticosteroid treatments appear to be effective in short term relief, it appears to have little or no significant impact on long-term recovery.
  • DMD Disease Modifying Drugs
  • interferon such as interferon, glatiramer acetate, fingolimod and tysabri
  • DMD's target inflammation and these drugs are designed to reduce the damage caused by relapses.
  • a common problem associated with DMD's are that they target the immune system, causing unpleasant and sometimes harmful side-effects. Treating a patient with DMD's can be very expensive, making it unaffordable to many. The use of injections is often necessary, necessitating multiple visits to a doctor, clinic or hospital. According to a study conducted by Modi et al in 2008, only about 22% of South Africans diagnosed with MS are treated with DMD's.
  • Nutritional supplement regimens may also be used in an attempt to reduce or even stop MS progression. These regimens typically include vitamins, minerals and more specialized nutritional elements. The problem associated with nutritional supplement regimens is that a wide variety of nutritional supplements are often needed in specific dosages by a patient suffering from MS or other demyelinating diseases. It can be very difficult to obtain each of the different nutritional supplements in the correct dosages from a store or pharmacy.
  • the typical nutritional supplement regimen for treating MS comprises in excess of 20 different nutritional supplements.
  • the intake of nutritional supplements plays a very important role in the treatment of demyelinating diseases, the intake of excessive amounts of a specific nutritional supplement may be to the detriment of patients.
  • Excess consumption of iron, for instance, can cause various stomach problems such as nausea, constipation and abdominal pain, whilst side-effects such as discoloration of teeth and skin disorders have also been reported.
  • a kit for use in a method of inhibiting damage or demise of myelin-producing cells comprises administering to a patient in need of such treatment an effective amount of a plurality of nutritional supplements; the kit having a container with a plurality of distinct compartments, each compartment containing a plurality of dosage units of the nutritional supplements, the nutritional supplements constituting sufficient daily multi-unit doses for a period of time.
  • the nutritional supplements to be selected from iron, essential amino acids, lipids, minerals and vitamins.
  • the amino acids to be selected from leucine, isoleucine, lysine, tryptophan, methionine, phenylalanine, threonine, valine and histidine;
  • the lipids to be selected from the list comprising evening primrose oil, salmon oil and lecithin;
  • the vitamins to be selected from the list comprising beta carotene, vitamin C, vitamin E, vitamin B1 , vitamin B2, nicotinamide, folic acid, vitamin B12, vitamin B6, pantothenate, vitamin D2 and vitamin D3;
  • the minerals to be selected from the list comprising calcium, magnesium, copper, zinc, manganese, chromium, molybdenum and selenium.
  • the nutritional supplements to be administered as an oral dosage forms such as tablets, capsules, fluids, powders or dietary shakes; and for a dosage form to include two or more of the nutritional supplements.
  • kit to include one or more amino acids in the following amounts:
  • kit to include one or more lipids in the following amounts: approximately 500mg evening primrose oil; approximately 500mg salmon oil; and approximately 300mg lecithin.
  • kit to include one or more vitamins in the following amounts:
  • kit to include one or more minerals in the following amounts:
  • kit to include 1235mg leucine, 890mg isoleucine, 995mg lysine, 175mg tryptophan, 3154mg methionine, 610mg phenylalanine, 570mg threonine, 840mg valine, 340mg histidine, 3mg beta carotene, 350mg vitamin C, 40mg vitamin E, 3mg vitamin B1 , 4mg vitamin B2, 20mg nicotinamide, 5mg folic acid, 24 ⁇ g vitamin B12, 10mg vitamin B6, 10mg pantothenate, 50 000 IU mg vitamin D2, 500 IU vitamin D3, 28.5mg calcium, 150mg magnesium, 1 mg copper, 15mg zinc, 2,5mg manganese, 100 ⁇ g chromium, 100 ⁇ g molybdenum and 60 ⁇ g selenium and optionally 15mg iron.
  • each compartment of the kit to contain multiple dosage units of the same nutritional supplement; alternatively for the kit to have at least 28 compartments containing a daily dosage unit of each of the different nutritional supplements; for each of the compartments to have a separate cap and for the kit to have at least one lid covering the compartments and corresponding caps.
  • a nutritional composition for use in a method of inhibiting damage or demise of myelin-producing cells, which method comprises administering to a patient in need of such treatment an effective amount of a plurality of nutritional supplements; the nutritional supplements including essential amino acids, lipids, minerals, vitamins and optionally iron.
  • the nutritional composition to include one or more amino acids selected from leucine, isoleucine, lysine, tryptophan, methionine, phenylalanine, threonine, valine and histidine in the following amounts:
  • the nutritional composition to include one or more lipids in the following amounts: about 500mg evening primrose oil;
  • the nutritional composition to include one or more vitamins in the following amounts:
  • the nutritional composition to include one or more minerals in the following amounts:
  • the nutritional composition comprises 1235mg leucine, 890mg isoleucine, 995mg lysine, 175mg tryptophan, 3154mg methionine, 610mg phenylalanine, 570mg threonine, 840mg valine, 340mg histidine, 3mg beta carotene, 350mg vitamin C, 40mg vitamin E, 3mg vitamin B1 , 4mg vitamin B2, 20mg nicotinamide, 5mg folic acid, 24 ⁇ g vitamin B12, 10mg vitamin B6, 10mg pantothenate, 50 000 IU mg vitamin D2, 500 IU vitamin D3, 28.5mg calcium, 150mg magnesium, 1 mg copper, 15mg zinc, 2,5mg manganese, 100 ⁇ g chromium, 100 ⁇ g molybdenum and 60 ⁇ g selenium and optionally 15mg iron.
  • Still further features of this aspect of the invention provide for the nutritional supplements of the nutritional composition to be contained in a plurality of dosage units; for the dosage units to be selected from tablets, capsules, fluids, powders and dietary shakes; and for one or more of the dosage units to contain two or more of the nutritional supplements.
  • a kit comprises a container having a plurality of distinct compartments. Each of the compartments contains a plurality of dosage units of various nutritional supplements.
  • the plurality of nutritional supplements constitutes a multi-unit dose used in a method of inhibiting damage or demise of myelin-producing cells.
  • each compartment contains multiple dosage units of the same nutritional supplement.
  • the kit has at least 28 compartments containing a daily dosage unit of each of the different nutritional supplements. It is appreciated that the kit can also comprise 30 or 31 compartments, each compartment representing a day of the month. Each of the compartments may have a separate cap as it may not be necessary to consume each of the supplements every day. A single lid may also be provided to cover the separate compartments and corresponding caps.
  • the caps may be of the screw-on type, but a person skilled in the art will appreciate that various different types of caps may be used.
  • the compartments may also be arranged in a specific sequence such as days of the month or in a sequence indicating days of the week and weeks of the month.
  • each of the compartments may depict certain information, or may include means for receiving substantially flat articles, such as stickers or slide-in plates depicting information such as dosages and side effects.
  • the kit may also include one or more additional storage areas for storing articles such as documents pertaining to the nutritional supplements and medical reports. Additional storage areas may also be included in the kit to store spoons or measuring devices used for measuring fluids or powders.
  • kit may be manufactured in different shapes and sizes and also that the size and depth of the compartments may vary in order to accommodate the various different nutritional supplements.
  • the nutritional supplements are administered to patients in need of such treatment in therapeutically effective amounts. If a person suffers from demyelinating diseases, important myelin producing cells glial cells, such as oligodendrocytes and Schwann cells are often destroyed. In order for remyelination of lesions to occur, it is thus important to inhibit, ameliorate or alleviate the apoptosis of myelin-producing cells.
  • Various nutritional supplements are needed in order to achieve this in order to improve myelin repair and regeneration.
  • the nutritional supplements typically comprise iron, essential amino acids, lipids, minerals and vitamins. Each supplement plays a very specific and important role in the regeneration of myelin.
  • Vascular damage in MS is implicated in the finding of higher homocysteine levels in patients diagnosed with MS.
  • Prolonged iron deficiency anaemia is associated with gastritis and atrophy of lands producing intrinsic factor in the stomach. This leads to a decrease in vitamin B12 absorption by the body.
  • Optimal functioning of the folate-vitamin B12-methyl transfer cycle continuously providing activated methyl-groups is a prerequisite for myelin production and maintenance and long-term deficiencies such as an iron deficiency may cause demyelination diseases of the brain and spinal cord.
  • Iron will typically be administered as a bisglycinate amino acid chelate and may be provided as a separate dosage form and may be excluded from the kit depending on the iron levels of a patient.
  • the kit may include one or more of the following amino acids: leucine, isoleucine, lysine, tryptophan, methionine, phenylalanine, threonine, valine and histidine.
  • the kit typically contains one or more of the amino acids in the following amounts: approximately 1235mg leucine;
  • the kit may further include one or more of evening primrose oil, lecithin and fish oils such as salmon oil, which are rich in essential omega oils.
  • the kit typically includes one or more of these lipids in the following amounts:
  • the kit also includes one or more of the following vitamins: beta carotene, vitamin C, vitamin E, vitamin B1 , vitamin B2, nicotinamide, folic acid, vitamin B12, vitamin B6, pantothenate, vitamin D2 and vitamin D3.
  • the kit typically includes one or more of these vitamins in the following amounts: approximately 3mg beta carotene;
  • panthothenate approximately 10mg panthothenate
  • vitamin D2 in the kit is vital in some cases.
  • a genetic defect occurs in the enzyme CYP12B1 , which activates vitamin D3.
  • the administering of vitamin D2 will be beneficial at the activated forms of both vitamin D3 and vitamin D2 bind to vitamin D receptors and are therefore equally metabolically active.
  • a genetic metabolic block often present in patients with demyelination diseases, is bypassed by stimulation an alternative metabolic pathway.
  • genetic defects in the enzyme MTHFR which activates tetrahydrofolate, can reduce the activity of the enzyme by 30% or more, affecting myelin production and repair. Increasing the amount of folate included in the kit, the activity of the enzyme is restored.
  • the kit may include the following minerals: calcium, magnesium, copper, zinc, manganese, chromium, molybdenum or selenium.
  • the kit typically includes one or more of these minerals in the following amounts: approximately 28.5mg calcium;
  • the nutritional kit may include 10% more or 10% less of iron, amino acids, lipids, vitamins and minerals as set out above.
  • the kit will include 1235mg leucine, 890mg isoleucine, 995mg lysine, 175mg tryptophan, 3154mg methionine, 610mg phenylalanine, 570mg threonine, 840mg valine, 340mg histidine, 3mg beta carotene, 350mg vitamin C, 40mg vitamin E, 3mg vitamin B1 , 4mg vitamin B2, 20mg nicotinamide, 5mg folic acid, 24 ⁇ g vitamin B12, 10mg vitamin B6, 10mg pantothenate, 28.5mg calcium, 150mg magnesium, 1 mg copper, 15mg zinc, 2,5mg manganese, 10C ⁇ g chromium, 100 ⁇ g molybdenum and 6C ⁇ g selenium and optionally 15mg iron, 50 000 IU vitamin D2 and 500 IU vitamin D3.
  • the nutritional supplements may be oral dosage forms such as powders, dietary shakes, tablets, capsules or fluids.
  • the nutritional supplements are included in the compartments as a first dosage unit containing iron; a second dosage unit in the form of protein powder containing one or more of rice protein, whey protein, soy protein and lecithin; a third dosage unit containing multiple vitamins; a fourth dosage unit containing antioxidants; a fifth dosage unit containing minerals and trace elements; a sixth dosage unit containing salmon oil; and a seventh dosage unit containing evening primrose oil.
  • the first dosage unit may contain iron as bisglycinate amino acid chelate or other similar iron compounds providing between 10.50mg and 17.5mg, but preferably 14mg elemental iron per day for approximately one month.
  • the iron may be provided in a separate container and added to the kit for patients who present with low iron parameters.
  • the second dosage unit may consist of whey powder, soy powder or rice powder which provide between 20g and 40g, but preferably 30g of protein per day, in combination with between 300mg and 1200mg lecithin per day for approximately one month.
  • the protein powder typically includes:
  • the third dosage unit may be in an oral dosage form such as a tablet or capsule containing approximately 100mg biotin, approximately 20mg co- enzyme Q10, approximately 800mcg folic acid, approximately 10mg pantothenate, approximately 333 IU vitamin A in the form of beta carotene, approximately 24mcg vitamin B1 in the form of methylcobalamin; approximately 4mg vitamin B2, approximately 18mg vitamin B3 in the form of nicotenamid, 10mg of vitamin B2 and approximately 500 IU vitamin D3.
  • an oral dosage form such as a tablet or capsule containing approximately 100mg biotin, approximately 20mg co- enzyme Q10, approximately 800mcg folic acid, approximately 10mg pantothenate, approximately 333 IU vitamin A in the form of beta carotene, approximately 24mcg vitamin B1 in the form of methylcobalamin; approximately 4mg vitamin B2, approximately 18mg vitamin B3 in the form of nicotenamid, 10mg of vitamin B2 and
  • the concentration of vitamin D3 will typically be 500 IU per day, however if a genetic variation is discovered in a patient that blocks the activation of vitamin D3, vitamin D2 may be added to the regimen.
  • the concentration of vitamin D2 will typically be 50 000 IU per day until blood levels normalise to 50ng - 100ng.
  • the concentration of vitamin D2 advised may then be reduced to 50 000 IU 3 times per week.
  • the fourth dosage unit may be in the form of a capsule or tablet containing approximately 120mg alpha lipoic acid, approximately 4mg of 5% extract of astaxanthin, approximately 30mg of grape seed extract, approximately 30mg of resveratrol, approximately 100mg of rooibos teas exteract, approximately 50 mg roship vitamin C, approximately 10mg 0.3% sulforaphane, approximately 1665 IU vitamin A in the form of beta carotene, approximately 15 IU alpha tocopherol and approximately 100 meg elemental L- selenomethionine.
  • the fourth dosage unit is illustrated in table 3 below.
  • the fifth dosage unit may be a capsule or tablet containing approximately 3mg boron, approximately 100mg calcium, approximately 120 meg chromium in the form of niccotinoglycinate amino acid chelate, approximately 2mg copper, approximately 100mg magnesium as glycinate amino acid chelate or magnesium oxide, approximately 75 meg molybdenum, approximately 100mg potassium in the form of potassium glycinate amino acid complex or potassium gluconate or asparate or citrate or iodide, approximately 15mg zinc in the form of ACC, approximately 100mg salmon oil and approximately 500mg evening primrose oil.
  • the fifth dosage unit is illustrated in table 4 below.
  • the sixth dosage unit typically contains 1000mg salmon oil and 500mg evening primrose oil as illustrated in table 5.
  • additional Salmon Oil may be taken in the morning, the concentration whereof may vary between 500 - 1000 mg. This will be supplied as additional capsules.
  • a seventh dosage unit such as a capsule containing Lecithin, may be added if it is not included in the protein shake, or in addition to that which is contained in the protein shake:
  • the Lecithin may also be supplied as granules to be sprinkled over breakfast cereal.
  • kits are used to treat patients with a regimen comprising of many different tablets, capsules, fluids or powders. It is difficult to find all the nutritional supplements needed from a single store or pharmacy. Even if all the supplements can be obtained from a single store or pharmacy, it can be a hassle to carry the different nutritional supplements around.
  • An advantage of the kit is that all the nutritional supplements are contained in a single kit which is easy to carry and which may include instructions and important information as to the use thereof. This will increase patient compliance and consequently increase the therapeutic benefits of using nutritional supplements.
  • EDSS Expanded Disability Status Scale
  • Table 7 illustrates the results of the EDSS neurological examination of the 12 compliant patents at baseline and after 6 months.
  • the mean total EDSS score improved significantly from 3.50 ⁇ 0.57 at baseline to 2.45 ⁇ 0.50 at endpoint. The most dramatic improvement was recorded in the cerebral sub- scale of the EDS, which measures mood and mentation. All patients recorded zero deficits after 6 months. Two patents had a score of 0 on the total EDSS after 6 months, indicating no neurological disability.
  • Raphah Regimen including iron
  • Vitamin D was measured in a person diagnosed with MS who was wheelchair bound. Her serum vitamin D concentration was 6 ng/l, whereas values less than 30 ng/l are considered to be deficient. Values of 60 - 100 ng/l are considered to be optimal. Due to the exceptionally low serum value of vitamin D it was decided to prescribe 50000 IU of vitamin D2, to bypass possible genetic blocks in vitamin D3 activation. The results were surprising. Within a day the patient experienced improvement in three areas and which are enduring as long as she takes the vitamin D2: in her balance, her eyesight and her mood.
  • a nutritional composition for use in a method of inhibiting damage or demise of myelin-producing cells, the method comprising administering to a patient in need of such treatment an effective amount of a plurality of nutritional supplements; the composition including iron, essential amino acids, lipids, minerals and vitamins.
  • the composition including iron, essential amino acids, lipids, minerals and vitamins.
  • the nutritional supplements are typically contained in a plurality of dosage units, together making up the nutritional composition.
  • the dosage units include tablets, capsules, fluids, powders and dietary shakes.
  • the nutritional composition may include one of more amino acids in the following amounts:
  • the nutritional composition may further include one or more of the following lipids, typically in the following amounts: Approximately 500mg evening primrose oil; approximately 500mg salmon oil; and approximately 300mg lecithin.
  • the nutritional composition may include one or more of the following vitamins, typically in the following amounts:
  • panthothenate approximately 10mg panthothenate
  • the nutritional composition may include the following minerals, typically in the following amounts:
  • the nutritional composition may include 10% more or 10% less of each of the iron, amino acids, lipids, vitamins and minerals as set out above.
  • the nutritional composition comprises multiple dosage units, such as tablets, capsules, powders, dietary shakes and fluids.
  • the multiple dosage units collectively contain 1235mg leucine, 890mg isoleucine, 995mg lysine, 175mg tryptophan, 3154mg methionine, 610mg phenylalanine, 570mg threonine, 840mg valine, 340mg histidine, 3mg beta carotene, 350mg vitamin C, 40mg vitamin E, 3mg vitamin B1 , 4mg vitamin B2, 20mg nicotinamide, 5mg folic acid, 24 ⁇ g vitamin B12, 10mg vitamin B6, 10mg pantothenate, 50 000 IU mg vitamin D2, 500 IU vitamin D3, 28.5mg calcium, 150mg magnesium, 1 mg copper, 15mg zinc, 2,5mg manganese, 100 ⁇ g chromium, 100 ⁇ g molybden
  • one or more of the dosage units may include multiple nutritional supplements and that the nutritional supplements may be oral dosage forms such as powders, dietary shakes, tablets, capsules or fluids.
  • the nutritional composition comprises its nutritional supplements in the following dosage units:
  • a first dosage unit such as a tablet, capsule or other suitable dosage form containing iron
  • a second dosage unit such as protein powder containing one or more of rice protein, whey protein, soy protein and lecithin
  • a third dosage unit containing multiple vitamins
  • a fourth dosage unit containing antioxidants
  • a fifth dosage unit containing minerals and trace elements
  • a sixth dosage unit containing salmon oil
  • a seventh dosage unit containing evening primrose oil.
  • the first dosage unit may contain iron as bisglycinate amino acid chelate or other similar iron compounds providing between 10.50mg and 17.5mg, but preferably 14mg elemental iron per day for approximately one month.
  • the second dosage unit may be a protein powder consisting of whey powder, soy powder or rice powder which provide between 20g and 40g, but preferably 30g of protein per day, in combination with between 300mg and 1200mg lecithin per day for approximately one month.
  • the protein powder typically includes: g in
  • the third dosage unit may be in an oral dosage form such as a tablet or capsule containing approximately 100mg biotin, approximately 20mg coenzyme Q10, approximately 800mcg folic acid, approximately 10mg pantothenate, approximately 333 IU vitamin A in the form of beta carotene, approximately 24mcg vitamin B1 in the form of methylcobalamin;approximately 4mg vitamin B2, approximately 18mg vitamin B3 in the form of nicotenamid, 10mg of vitamin B2 and approximately 500 IU vitamin D3.
  • an oral dosage form such as a tablet or capsule containing approximately 100mg biotin, approximately 20mg coenzyme Q10, approximately 800mcg folic acid, approximately 10mg pantothenate, approximately 333 IU vitamin A in the form of beta carotene, approximately 24mcg vitamin B1 in the form of methylcobalamin;approximately 4mg vitamin B2, approximately 18mg vitamin B3 in the form of nicotena
  • the typical formulation of the third dosage unit is illustrated in table 1 1 .
  • the concentration of vitamin D3 will typically be 500 IU per day, however if a genetic variation is discovered in a patient that blocks the activation of vitamin D3, vitamin D2 may be added to the regimen.
  • the concentration of vitamin D2 will typically be 50 000 IU per day until blood levels normalise to 50ng - 100ng.
  • the concentration of vitamin D2 advised may then be reduced to 50 000 IU 3 times per week.
  • the fourth dosage unit may be in the form of a capsule or tablet containing approximately 120mg alpha lipoic acid, approximately 4mg of 5% extract of astaxanthin, approximately 30mg of grape seed extract, approximately 30mg of resveratrol, approximately 100mg of rooibos teas exteract, approximately 50 mg roship vitamin C, approximately 10mg 0.3% sulforaphane, approximately 1665 IU vitamin A in the form of beta carotene, approximately 15 IU alpha tocopherol and approximately 100 meg elemental L- selenomethionine.
  • the fourth dosage unit is illustrated in table 12 below.
  • the fifth dosage unit may be a capsule or tablet containing approximately 3mg boron, approximately 100mg calcium, approximately 120 meg chromium in the form of niccotinoglycinate amino acid chelate, approximately 2mg copper, approximately 100mg magnesium as glycinate amino acid chelate or magnesium oxide, approximately 75 meg molybdenum, approximately 100mg potassium in the form of potassium glycinate amino acid complex or potassium gluconate or asparate or citrate or iodide, approximately 15mg zinc in the form of ACC, approximately 100mg salmon oil and approximately 500mg evening primrose oil.
  • the fifth dosage unit is illustrated in table 13 below.
  • the sixth dosage unit typically contains 1000mg salmon oil and 500mg evening primrose oil as illustrated in table 14.
  • DHA Docosahexaenoic
  • additional Salmon Oil may be taken in the morning, the concentration whereof may vary between 500 - 1000 mg. This will be supplied as additional capsules.
  • a seventh dosage unit consisting of capsules containing Lecithin, may be added if it is not included in the protein shake, or in addition to that which is contained in the protein shake:
  • the Lecithin may also be supplied as granules to be sprinkled over breakfast cereal.

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Abstract

A kit for use in a method of inhibiting damage or demise of myelin-producing cells is disclosed. The method includes administering to a patient in need of such treatment an effective amount of a plurality of nutritional supplements. The kit has a container with a plurality of distinct compartments, each compartment containing a plurality of dosage units of the nutritional supplements, such as minerals, vitamins, essential amino acids and iron. The nutritional supplements constitutes sufficient daily multi-unit doses for a period of time.

Description

NUTRITIONAL KIT
FIELD OF THE INVENTION
The present invention relates to a nutritional a kit for use in the treatment and management of demyelinating diseases.
BACKGROUND TO THE INVENTION
Demyelinating diseases such as Multiple Sclerosis ("MS"), clinically isolated syndrome, psychiatric diseases such as depression and bipolar disorder, ADHD, mild cognitive impairment, developmental delay and peripheral demyelinating disorders are difficult to accurately diagnose and treat. Patients suffering from demyelinating diseases present with various clinical symptoms, which is illustrated well by MS.
MS is a disorder in which autoreactive immune responses are involved in the attack on myelinated axons, causing lesions or scars in the insulating myelin sheth protecting axons. These lesions then interfere with the conduction of signals to the periphery. The disease process is typically progressive and can lead to chronic disability.
Patients sometimes experience a remission after initial diagnosis. After an initial remission, some patients experience few symptoms for long periods of time, while others deteriorate rapidly.
The central nervous system is made up of nerves that act as the body's messenger system. Each nerve is covered by a fatty substance called myelin, which insulates the nerves and helps in the transmission of nerve impulses between the brain and other parts of the body. With demyelinating diseases such as MS, the myelin that protects the nerves is destroyed, causing scar tissue. This process is called demyelination. Without the myelin, electrical signals transmitted throughout the brain and spinal cord are disrupted or halted. The brain thus becomes unable to send and receive messages, causing a multitude of symptoms.
Myelin regeneration is a prerequisite for remission and various nutrients, such as iron, essential amino acids, lipids, vitamins and minerals play an important role in the regeneration of myelin.
Suitable treatment of demyelinating diseases depends largely on the type of demyelinating disease that the patient suffers from and the symptoms that a patient presents with. In the case of acute attacks, patients must often be hospitalised. Furthermore, the routine therapy for acute relapses typically includes the administration of high doses of intravenous corticosteroids. Although corticosteroid treatments appear to be effective in short term relief, it appears to have little or no significant impact on long-term recovery.
Disease Modifying Drugs ("DMD") such as interferon, glatiramer acetate, fingolimod and tysabri are often used to delay long term progression of MS and to reduce the number of new lesions forming. DMD's target inflammation and these drugs are designed to reduce the damage caused by relapses. A common problem associated with DMD's are that they target the immune system, causing unpleasant and sometimes harmful side-effects. Treating a patient with DMD's can be very expensive, making it unaffordable to many. The use of injections is often necessary, necessitating multiple visits to a doctor, clinic or hospital. According to a study conducted by Modi et al in 2008, only about 22% of South Africans diagnosed with MS are treated with DMD's.
Nutritional supplement regimens may also be used in an attempt to reduce or even stop MS progression. These regimens typically include vitamins, minerals and more specialized nutritional elements. The problem associated with nutritional supplement regimens is that a wide variety of nutritional supplements are often needed in specific dosages by a patient suffering from MS or other demyelinating diseases. It can be very difficult to obtain each of the different nutritional supplements in the correct dosages from a store or pharmacy.
Another problem is the wide variety of products containing nutritional supplements that are available. The typical nutritional supplement regimen for treating MS comprises in excess of 20 different nutritional supplements. Although the intake of nutritional supplements plays a very important role in the treatment of demyelinating diseases, the intake of excessive amounts of a specific nutritional supplement may be to the detriment of patients. Excess consumption of iron, for instance, can cause various stomach problems such as nausea, constipation and abdominal pain, whilst side-effects such as discoloration of teeth and skin disorders have also been reported.
It is thus very important for a patient to consume the correct dosages of nutritional supplements when treating demyelinating diseases, such as MS.
SUMMARY OF THE INVENTION
In accordance with a first aspect of this invention there is provided a kit for use in a method of inhibiting damage or demise of myelin-producing cells, which method comprises administering to a patient in need of such treatment an effective amount of a plurality of nutritional supplements; the kit having a container with a plurality of distinct compartments, each compartment containing a plurality of dosage units of the nutritional supplements, the nutritional supplements constituting sufficient daily multi-unit doses for a period of time.
Further features of the invention provide for the nutritional supplements to be selected from iron, essential amino acids, lipids, minerals and vitamins. Even further features provide for the amino acids to be selected from leucine, isoleucine, lysine, tryptophan, methionine, phenylalanine, threonine, valine and histidine; for the lipids to be selected from the list comprising evening primrose oil, salmon oil and lecithin; for the vitamins to be selected from the list comprising beta carotene, vitamin C, vitamin E, vitamin B1 , vitamin B2, nicotinamide, folic acid, vitamin B12, vitamin B6, pantothenate, vitamin D2 and vitamin D3; and for the minerals to be selected from the list comprising calcium, magnesium, copper, zinc, manganese, chromium, molybdenum and selenium.
Yet further features provide for the nutritional supplements to be administered as an oral dosage forms such as tablets, capsules, fluids, powders or dietary shakes; and for a dosage form to include two or more of the nutritional supplements.
Even further features provide for the kit to include one or more amino acids in the following amounts:
1235mg leucine;
890mg isoleucine;
995mg lysine;
175mg tryptophane;
315mg methionine;
610mg phenylalanine;
570mg threonine;
840mg valine; and
340mg histidine.
Still further features provide for the kit to include one or more lipids in the following amounts: approximately 500mg evening primrose oil; approximately 500mg salmon oil; and approximately 300mg lecithin.
Yet further features provide for the kit to include one or more vitamins in the following amounts:
3mg beta carotene;
350mg vitamin C;
40mg vitamin E;
3mg vitamin B1 ;
4mg vitamin B2;
20mg nicotinaminde;
24μg vitamin B12;
10mg vitamin B6;
10mg panthothenate;
50 000 IU vitamin D2; and
500 IU vitamin D3;
Even further features provide for the kit to include one or more minerals in the following amounts:
28.5mg calcium;
150mg magnesium;
1 mg copper;
15mg zinc;
2.5mg manganese;
100μg chromium;
100μg molybdenum; and
60μg selenium.
Yet further features provide for the kit to include 1235mg leucine, 890mg isoleucine, 995mg lysine, 175mg tryptophan, 3154mg methionine, 610mg phenylalanine, 570mg threonine, 840mg valine, 340mg histidine, 3mg beta carotene, 350mg vitamin C, 40mg vitamin E, 3mg vitamin B1 , 4mg vitamin B2, 20mg nicotinamide, 5mg folic acid, 24 μg vitamin B12, 10mg vitamin B6, 10mg pantothenate, 50 000 IU mg vitamin D2, 500 IU vitamin D3, 28.5mg calcium, 150mg magnesium, 1 mg copper, 15mg zinc, 2,5mg manganese, 100μg chromium, 100μg molybdenum and 60μg selenium and optionally 15mg iron.
Still further features provide for each compartment of the kit to contain multiple dosage units of the same nutritional supplement; alternatively for the kit to have at least 28 compartments containing a daily dosage unit of each of the different nutritional supplements; for each of the compartments to have a separate cap and for the kit to have at least one lid covering the compartments and corresponding caps.
In accordance with a second aspect of the invention, there is provided a nutritional composition for use in a method of inhibiting damage or demise of myelin-producing cells, which method comprises administering to a patient in need of such treatment an effective amount of a plurality of nutritional supplements; the nutritional supplements including essential amino acids, lipids, minerals, vitamins and optionally iron.
Further features of this aspect of the invention provide for the nutritional composition to include one or more amino acids selected from leucine, isoleucine, lysine, tryptophan, methionine, phenylalanine, threonine, valine and histidine in the following amounts:
1235mg leucine;
890mg isoleucine;
995mg lysine;
175mg tryptophane;
315mg methionine;
610mg phenylalanine;
570mg threonine;
840mg valine; and
340mg histidine.
Still further features of the invention provide for the nutritional composition to include one or more lipids in the following amounts: about 500mg evening primrose oil;
about 500mg salmon oil;
about 300mg lecithin.
Even further features of the invention provide for the nutritional composition to include one or more vitamins in the following amounts:
3mg beta carotene;
350mg vitamin C;
40mg vitamin E;
3mg vitamin B1 ;
4mg vitamin B2;
20mg nicotinamide;
24μg vitamin B12;
10mg vitamin B6;
10mg panthothenate;
50 000 IU vitamin D2; and
500 IU vitamin D3;
Yet further features provide for the nutritional composition to include one or more minerals in the following amounts:
28.5mg calcium;
150mg magnesium;
1 mg copper;
15mg zinc;
2.5mg manganese;
100μg chromium;
100μg molybdenum; and
60μg selenium. An even further feature of the invention provides for the nutritional composition to comprise 1235mg leucine, 890mg isoleucine, 995mg lysine, 175mg tryptophan, 3154mg methionine, 610mg phenylalanine, 570mg threonine, 840mg valine, 340mg histidine, 3mg beta carotene, 350mg vitamin C, 40mg vitamin E, 3mg vitamin B1 , 4mg vitamin B2, 20mg nicotinamide, 5mg folic acid, 24 μg vitamin B12, 10mg vitamin B6, 10mg pantothenate, 50 000 IU mg vitamin D2, 500 IU vitamin D3, 28.5mg calcium, 150mg magnesium, 1 mg copper, 15mg zinc, 2,5mg manganese, 100μg chromium, 100μg molybdenum and 60μg selenium and optionally 15mg iron.
Still further features of this aspect of the invention provide for the nutritional supplements of the nutritional composition to be contained in a plurality of dosage units; for the dosage units to be selected from tablets, capsules, fluids, powders and dietary shakes; and for one or more of the dosage units to contain two or more of the nutritional supplements.
DETAILED DESCRIPTION OF THE INVENTION
A kit is provided that comprises a container having a plurality of distinct compartments. Each of the compartments contains a plurality of dosage units of various nutritional supplements. The plurality of nutritional supplements constitutes a multi-unit dose used in a method of inhibiting damage or demise of myelin-producing cells.
In one embodiment of the invention, each compartment contains multiple dosage units of the same nutritional supplement.
In a different embodiment of the invention the kit has at least 28 compartments containing a daily dosage unit of each of the different nutritional supplements. It is appreciated that the kit can also comprise 30 or 31 compartments, each compartment representing a day of the month. Each of the compartments may have a separate cap as it may not be necessary to consume each of the supplements every day. A single lid may also be provided to cover the separate compartments and corresponding caps.
The caps may be of the screw-on type, but a person skilled in the art will appreciate that various different types of caps may be used. The compartments may also be arranged in a specific sequence such as days of the month or in a sequence indicating days of the week and weeks of the month.
In a further embodiment each of the compartments may depict certain information, or may include means for receiving substantially flat articles, such as stickers or slide-in plates depicting information such as dosages and side effects.
The kit may also include one or more additional storage areas for storing articles such as documents pertaining to the nutritional supplements and medical reports. Additional storage areas may also be included in the kit to store spoons or measuring devices used for measuring fluids or powders.
It will be appreciated that the kit may be manufactured in different shapes and sizes and also that the size and depth of the compartments may vary in order to accommodate the various different nutritional supplements.
The nutritional supplements are administered to patients in need of such treatment in therapeutically effective amounts. If a person suffers from demyelinating diseases, important myelin producing cells glial cells, such as oligodendrocytes and Schwann cells are often destroyed. In order for remyelination of lesions to occur, it is thus important to inhibit, ameliorate or alleviate the apoptosis of myelin-producing cells. Various nutritional supplements are needed in order to achieve this in order to improve myelin repair and regeneration. The nutritional supplements typically comprise iron, essential amino acids, lipids, minerals and vitamins. Each supplement plays a very specific and important role in the regeneration of myelin.
Some patients suffering from MS present with low blood iron concentrations. A prerequisite for the regeneration of myelin is sufficient levels of iron and a functional folate-vitamin B12-methylation pathway. Iron deficiency can result in a reduced amount of myelin in the spinal cord and white matter of patients. Studies further suggest that many of the enzymes involved in the biosynthetic pathways that produce myelin utilise iron as part of their catalytic centre.
Vascular damage in MS is implicated in the finding of higher homocysteine levels in patients diagnosed with MS. Prolonged iron deficiency anaemia is associated with gastritis and atrophy of lands producing intrinsic factor in the stomach. This leads to a decrease in vitamin B12 absorption by the body. Optimal functioning of the folate-vitamin B12-methyl transfer cycle continuously providing activated methyl-groups is a prerequisite for myelin production and maintenance and long-term deficiencies such as an iron deficiency may cause demyelination diseases of the brain and spinal cord.
Iron will typically be administered as a bisglycinate amino acid chelate and may be provided as a separate dosage form and may be excluded from the kit depending on the iron levels of a patient.
Essential amino acids are essential building blocks and play an important role in the general well-being of patients diagnosed with demyelinating diseases such as MS. A lack of these amino acids may disrupt metabolic processes causing and worsening symptoms such as weakness, fatigue and lethargy. The kit may include one or more of the following amino acids: leucine, isoleucine, lysine, tryptophan, methionine, phenylalanine, threonine, valine and histidine. The kit typically contains one or more of the amino acids in the following amounts: approximately 1235mg leucine;
approximately 890mg isoleucine;
approximately 995mg lysine;
approximately 175mg tryptophane;
approximately 315mg methionine;
approximately 610mg phenylalanine;
approximately 570mg threonine;
approximately 840mg valine; and
approximately 340mg histidine.
The kit may further include one or more of evening primrose oil, lecithin and fish oils such as salmon oil, which are rich in essential omega oils. The kit typically includes one or more of these lipids in the following amounts:
Approximately 500mg evening primrose oil; approximately 500mg salmon oil; and approximately 300mg lecithin.
The kit also includes one or more of the following vitamins: beta carotene, vitamin C, vitamin E, vitamin B1 , vitamin B2, nicotinamide, folic acid, vitamin B12, vitamin B6, pantothenate, vitamin D2 and vitamin D3. The kit typically includes one or more of these vitamins in the following amounts: approximately 3mg beta carotene;
approximately 350mg vitamin C;
approximately 40mg vitamin E;
approximately 3mg vitamin B1 ;
approximately 4mg vitamin B2;
approximately 20mg nicotinaminde;
approximately 24μg vitamin B12; approximately 10mg vitamin B6;
approximately 10mg panthothenate;
approximately 50 000 IU vitamin D2; and
approximately 500 IU vitamin D3.
The inclusion of vitamin D2 in the kit is vital in some cases. In some patients, a genetic defect occurs in the enzyme CYP12B1 , which activates vitamin D3. In such cases, the administering of vitamin D2 will be beneficial at the activated forms of both vitamin D3 and vitamin D2 bind to vitamin D receptors and are therefore equally metabolically active. In this manner, a genetic metabolic block often present in patients with demyelination diseases, is bypassed by stimulation an alternative metabolic pathway.
Similarly, genetic defects in the enzyme MTHFR, which activates tetrahydrofolate, can reduce the activity of the enzyme by 30% or more, affecting myelin production and repair. Increasing the amount of folate included in the kit, the activity of the enzyme is restored.
The kit may include the following minerals: calcium, magnesium, copper, zinc, manganese, chromium, molybdenum or selenium. The kit typically includes one or more of these minerals in the following amounts: approximately 28.5mg calcium;
approximately 150mg magnesium;
approximately 1 mg copper;
approximately 15mg zinc;
approximately 2.5mg manganese;
approximately 100μg chromium;
approximately 100μg molybdenum; and
approximately 60μg selenium.
It will be appreciated that the nutritional kit may include 10% more or 10% less of iron, amino acids, lipids, vitamins and minerals as set out above.
In a preferred embodiment of the invention the kit will include 1235mg leucine, 890mg isoleucine, 995mg lysine, 175mg tryptophan, 3154mg methionine, 610mg phenylalanine, 570mg threonine, 840mg valine, 340mg histidine, 3mg beta carotene, 350mg vitamin C, 40mg vitamin E, 3mg vitamin B1 , 4mg vitamin B2, 20mg nicotinamide, 5mg folic acid, 24 μg vitamin B12, 10mg vitamin B6, 10mg pantothenate, 28.5mg calcium, 150mg magnesium, 1 mg copper, 15mg zinc, 2,5mg manganese, 10C^g chromium, 100μg molybdenum and 6C^g selenium and optionally 15mg iron, 50 000 IU vitamin D2 and 500 IU vitamin D3.
The nutritional supplements may be oral dosage forms such as powders, dietary shakes, tablets, capsules or fluids.
In one embodiment of the invention the nutritional supplements are included in the compartments as a first dosage unit containing iron; a second dosage unit in the form of protein powder containing one or more of rice protein, whey protein, soy protein and lecithin; a third dosage unit containing multiple vitamins; a fourth dosage unit containing antioxidants; a fifth dosage unit containing minerals and trace elements; a sixth dosage unit containing salmon oil; and a seventh dosage unit containing evening primrose oil.
The first dosage unit may contain iron as bisglycinate amino acid chelate or other similar iron compounds providing between 10.50mg and 17.5mg, but preferably 14mg elemental iron per day for approximately one month. The iron may be provided in a separate container and added to the kit for patients who present with low iron parameters.
The second dosage unit may consist of whey powder, soy powder or rice powder which provide between 20g and 40g, but preferably 30g of protein per day, in combination with between 300mg and 1200mg lecithin per day for approximately one month.
The protein powder typically includes:
Figure imgf000015_0001
Table 1
The third dosage unit may be in an oral dosage form such as a tablet or capsule containing approximately 100mg biotin, approximately 20mg co- enzyme Q10, approximately 800mcg folic acid, approximately 10mg pantothenate, approximately 333 IU vitamin A in the form of beta carotene, approximately 24mcg vitamin B1 in the form of methylcobalamin; approximately 4mg vitamin B2, approximately 18mg vitamin B3 in the form of nicotenamid, 10mg of vitamin B2 and approximately 500 IU vitamin D3.
The typical formulation of the third dosage unit is illustrated in table 2.
Figure imgf000016_0001
Table 2
The concentration of vitamin D3 will typically be 500 IU per day, however if a genetic variation is discovered in a patient that blocks the activation of vitamin D3, vitamin D2 may be added to the regimen. The concentration of vitamin D2 will typically be 50 000 IU per day until blood levels normalise to 50ng - 100ng. The concentration of vitamin D2 advised may then be reduced to 50 000 IU 3 times per week.
The fourth dosage unit may be in the form of a capsule or tablet containing approximately 120mg alpha lipoic acid, approximately 4mg of 5% extract of astaxanthin, approximately 30mg of grape seed extract, approximately 30mg of resveratrol, approximately 100mg of rooibos teas exteract, approximately 50 mg roship vitamin C, approximately 10mg 0.3% sulforaphane, approximately 1665 IU vitamin A in the form of beta carotene, approximately 15 IU alpha tocopherol and approximately 100 meg elemental L- selenomethionine.
The fourth dosage unit is illustrated in table 3 below.
Figure imgf000017_0001
Table 3
The fifth dosage unit may be a capsule or tablet containing approximately 3mg boron, approximately 100mg calcium, approximately 120 meg chromium in the form of niccotinoglycinate amino acid chelate, approximately 2mg copper, approximately 100mg magnesium as glycinate amino acid chelate or magnesium oxide, approximately 75 meg molybdenum, approximately 100mg potassium in the form of potassium glycinate amino acid complex or potassium gluconate or asparate or citrate or iodide, approximately 15mg zinc in the form of ACC, approximately 100mg salmon oil and approximately 500mg evening primrose oil. The fifth dosage unit is illustrated in table 4 below.
Minerals and Trace elements (Capsule
or Tablet) Values Units Lowest Highest
Figure imgf000018_0001
Table 4
The sixth dosage unit typically contains 1000mg salmon oil and 500mg evening primrose oil as illustrated in table 5.
Figure imgf000018_0002
Table 5
In the case where patients are diagnosed with a mental condition such as depression, additional Salmon Oil may be taken in the morning, the concentration whereof may vary between 500 - 1000 mg. This will be supplied as additional capsules.
A seventh dosage unit, such as a capsule containing Lecithin, may be added if it is not included in the protein shake, or in addition to that which is contained in the protein shake:
Figure imgf000018_0003
The Lecithin may also be supplied as granules to be sprinkled over breakfast cereal.
Patient compliance is a problem when treating patients with a regimen comprising of many different tablets, capsules, fluids or powders. It is difficult to find all the nutritional supplements needed from a single store or pharmacy. Even if all the supplements can be obtained from a single store or pharmacy, it can be a hassle to carry the different nutritional supplements around. An advantage of the kit is that all the nutritional supplements are contained in a single kit which is easy to carry and which may include instructions and important information as to the use thereof. This will increase patient compliance and consequently increase the therapeutic benefits of using nutritional supplements.
Case Studies
Case Study 1
Thirty one patients suffering from MS took part in a case study directed at treatment with the nutritional supplements forming part of the nutritional kit of this invention.
As part of the study, an evaluation was made of the possible benefits of the nutritional supplement regimen of this invention. The "Raphah Regimen" as illustrated in table 6, was offered to each of the participants. Out of a smaller group of eighteen, twelve of the patients participating in the trial closely followed the regimen ("the compliant group"), while six of the patients did not follow the regimen ("the non-compliant group").
Expanded Disability Status Scale ("EDSS") neurological determinations and laboratory tests were conducted on the eighteen volunteers at baseline and after 6 months. Vitamins and
RDA
Minerals
Iron* 15 mg/day Beta Carotene 3 mg -
Vitamin C 350mg
777
Essential amino acids Vitamin E 40mg
266
(e.a. diet milk shake)
Vitamin B1 3mg
200
Leucine 1235mg Vitamin B2 4mg 222
Isoleucine 890mg Nicotinamide 20mg
100
Lysine 995mg Folic Acid 5mg
1250
Tryptophan 175mg Vitamin B12** 24μ9
800
Methionine 315mg Vitamin B6 10mg
500
Phenylalanine 610mg Pantothenate 10mg 130
Treonine 570mg Calcium 28.5mg 2
Valine 840mg Magnesium 150mg
37
Histidine 340mg Copper 1mg 50
Zinc 15mg 100
Lipids Manaanese 2.5m -
Evening Primrose Oil 500mg Chromium 100μ9 -
Salmon Oil 500mg Molybdenum 100μ9 -
Lecithin 300mg Selenium 60μ9-
Table 6
Table 7 illustrates the results of the EDSS neurological examination of the 12 compliant patents at baseline and after 6 months. The mean total EDSS score improved significantly from 3.50±0.57 at baseline to 2.45±0.50 at endpoint. The most dramatic improvement was recorded in the cerebral sub- scale of the EDS, which measures mood and mentation. All patients recorded zero deficits after 6 months. Two patents had a score of 0 on the total EDSS after 6 months, indicating no neurological disability. For one of the compliant patients on the Raphah Regimen (including iron), MRI scans done after 6 months, after 24 months and again after 30 months, showed no additional intense lesions, and no disease activity on gadolinium enhancement.
Patients taking iron Patients not taking iron Baseline 6 months Baseline 6 months
Serum iron 14.04±0.95 15.46±1 .82 19.23±1 .43 15.7512.21 (μπιοΙ/L)
Transferrin 2.48±0.13 2.14±0.1 1 2.29±0.15 2.0010.24
(g/L)
% sat 23.52±2.80 28.93±4.60 32.67±1 .29 30.1611 .92 Transferrin
Ferritin 30.55±4.61 34.26±6.41 108.55141 .19 1 12.02137.51 (ng/ml)
Haemoglobin 13.7±0.2 13.9±0.3 15.210.3 14.910.4 (g/dl)
Serum folate 25.6±6.8 31 .6±6.0 28.619.6 35.119.9 (nmol/L)
Homocysteine 9.1 ±2.1 6.4±0.4 6.711 .4 6.210.9
(μπιοΙ/L)
CRP 5.4±3.6 2.5±1 .2 1 .910.7 2.011 .0
Table 7
No-one from the compliant group was admitted to hospital for intravenous prednisone treatment during the 6 month period, while 1 on the non- compliant group received intravenous prednisone. The neurological outcome in the non-compliance group was deterioration from a mean total EDSS score of 4.8310.84 to 5.5010.55 at 6 months. There was also a significant difference in neurological outcome when the compliant and non-compliant groups were compared.
A follow-up analysis was conducted in respect of the patients several years later. Ten out of twelve patients from the compliant group showed a positive change in their EDSS scores. The change in EDSS scores ranged from 0.5 to 5.0. The EDSS score of one of the patients changed from 6 to 1 , which marks a surprisingly significant change. On average the change in EDSS scores was positive 1 .3.
Conversely, none of the patients in the non-compliant group showed a positive change in their EDSS scores and the average EDSS score was negative 1 .7.
Case Study 2
A 3-year old boy was presented to Tygerberg Children's Hospital. At the time he suffered from sleepiness and poor coordination. The MRI brain scan showed inflammation of the white matter. He responded well to the cortisone that was given to suppress the inflammation and he seemed to make a full recovery. Four months later, however, he again presented with headache and drowsiness. This time the MRI showed widespread inflammation of different parts of his brain. Once again, he responded to cortisone and it was continued for 3 months. In spite of this, he again developed headaches and loss of vision several months later. At this stage his eyes and optic nerves were inflamed and high doses of cortisone had to be given to prevent him from losing his sight altogether. The rapid succession of these episodes identified the disease as MS.
At this point blood iron levels were determined, confirming extremely low iron levels. Daily supplementation began to build up the depleted body stores. Since reversing the iron deficiency, he has been completely free of further episodes of inflammation for more than 5 years.
Case Study 3
Iron studies done over a period of 5 years for a person taking the Rapha Regimen. The results are presented in table 8.
Figure imgf000022_0001
RANGE
Haemoglobin 12.0
(g/dl) 15.0 10.3 - Low 14 1 1 .7 12.9
Serum Iron 10.0
(μπτιοΙ/Ι) 30.0 3.9 - Low 4.3- Low 16.3 20.5
Transferrin (g/l) 2.0 - 3.6 4.5 - High 4.0 - High 3.7 3.6
4%- V 4%- V
Tf Saturation (%) 15 - 30 Low Low 17% 22%
7 - Very
Ferritin
Figure imgf000023_0001
10 - 291 Low 27 20 51
Table 8
The normalisation of iron concentrations in the blood correlated with clinical outcome. The person's EDSS normalised to a score of 0 (no neurological deficit), and her MRI scans showed an improvement as well:
Neurologist's report: "FLAIR and T2 sequence hyperintensities which are perpendicularly orientated in relation to the ventricle (Dawson's fingers), and a pontine lesion" Follow-up MRI:
Radiologist's report: "The previous pontine lesion has resolved without residual signal changes and there is only slight scarring at the site of the previous right periventricular demyelinating lesions. No new or progressive lesions"
Case Study 4
Vitamin D was measured in a person diagnosed with MS who was wheelchair bound. Her serum vitamin D concentration was 6 ng/l, whereas values less than 30 ng/l are considered to be deficient. Values of 60 - 100 ng/l are considered to be optimal. Due to the exceptionally low serum value of vitamin D it was decided to prescribe 50000 IU of vitamin D2, to bypass possible genetic blocks in vitamin D3 activation. The results were surprising. Within a day the patient experienced improvement in three areas and which are enduring as long as she takes the vitamin D2: in her balance, her eyesight and her mood.
Case Study 5
A female diagnosed with MS presented with very low iron parameters. She was wheelchair bound. After taking iron supplements for a year, her iron had improved to almost normal. She has been able to regain the use of her legs, and is not in the wheelchair any more. Follow-up studies are planned.
Figure imgf000024_0001
Table 9
Also provided, is a nutritional composition for use in a method of inhibiting damage or demise of myelin-producing cells, the method comprising administering to a patient in need of such treatment an effective amount of a plurality of nutritional supplements; the composition including iron, essential amino acids, lipids, minerals and vitamins. In order for remyelination of lesions to occur, it is important to inhibit, ameliorate or alleviate the apoptosis of myelin-producing cells and each of the supplementary supplements plays a very specific and important role in the regeneration of myelin.
The nutritional supplements are typically contained in a plurality of dosage units, together making up the nutritional composition. The dosage units include tablets, capsules, fluids, powders and dietary shakes.
The nutritional composition may include one of more amino acids in the following amounts:
approximately 1235mg leucine;
approximately 890mg isoleucine;
approximately 995mg lysine;
approximately 175mg tryptophane;
approximately 315mg methionine;
approximately 610mg phenylalanine;
approximately 570mg threonine;
approximately 840mg valine; and
approximately 340mg histidine.
The nutritional composition may further include one or more of the following lipids, typically in the following amounts: Approximately 500mg evening primrose oil; approximately 500mg salmon oil; and approximately 300mg lecithin.
The nutritional composition may include one or more of the following vitamins, typically in the following amounts:
approximately 3mg beta carotene;
approximately 350mg vitamin C; approximately 40mg vitamin E;
approximately 3mg vitamin B1 ;
approximately 4mg vitamin B2;
approximately 20mg nicotinamide;
approximately 24μg vitamin B12;
approximately 10mg vitamin B6;
approximately 10mg panthothenate;
approximately 50 000 IU vitamin D2; and
approximately 500 IU vitamin D3.
The nutritional composition may include the following minerals, typically in the following amounts:
approximately 28.5mg calcium;
approximately 150mg magnesium;
approximately 1 mg copper;
approximately 15mg zinc;
approximately 2.5mg manganese;
approximately 100μg chromium;
approximately 100μg molybdenum; and
approximately 60μg selenium.
It will be appreciated that the amounts mentioned in this specification are exemplary and that it should not be interpreted to be limiting. It is envisaged that the nutritional composition may include 10% more or 10% less of each of the iron, amino acids, lipids, vitamins and minerals as set out above.
In a preferred embodiment of the nutritional composition, it comprises multiple dosage units, such as tablets, capsules, powders, dietary shakes and fluids. The multiple dosage units collectively contain 1235mg leucine, 890mg isoleucine, 995mg lysine, 175mg tryptophan, 3154mg methionine, 610mg phenylalanine, 570mg threonine, 840mg valine, 340mg histidine, 3mg beta carotene, 350mg vitamin C, 40mg vitamin E, 3mg vitamin B1 , 4mg vitamin B2, 20mg nicotinamide, 5mg folic acid, 24 μg vitamin B12, 10mg vitamin B6, 10mg pantothenate, 50 000 IU mg vitamin D2, 500 IU vitamin D3, 28.5mg calcium, 150mg magnesium, 1 mg copper, 15mg zinc, 2,5mg manganese, 100μg chromium, 100μg molybdenum and 60μg selenium and optionally 15mg iron.
It should be appreciated that one or more of the dosage units may include multiple nutritional supplements and that the nutritional supplements may be oral dosage forms such as powders, dietary shakes, tablets, capsules or fluids.
In one embodiment, the nutritional composition comprises its nutritional supplements in the following dosage units:
A first dosage unit, such as a tablet, capsule or other suitable dosage form containing iron; a second dosage unit, such as protein powder containing one or more of rice protein, whey protein, soy protein and lecithin; a third dosage unit containing multiple vitamins; a fourth dosage unit containing antioxidants; a fifth dosage unit containing minerals and trace elements; a sixth dosage unit containing salmon oil; and a seventh dosage unit containing evening primrose oil.
The first dosage unit may contain iron as bisglycinate amino acid chelate or other similar iron compounds providing between 10.50mg and 17.5mg, but preferably 14mg elemental iron per day for approximately one month.
The second dosage unit may be a protein powder consisting of whey powder, soy powder or rice powder which provide between 20g and 40g, but preferably 30g of protein per day, in combination with between 300mg and 1200mg lecithin per day for approximately one month.
The protein powder typically includes: g in
A
1000g Lowest Highest
L-Alanine 16.5 12.38 20.63
L-Arginine 21 .8 16.35 27.25
L-Aspartic Acid 35.3 26.48 44.13
L-Cysteine 2.4 1 .80 3.00
L-Glutamine 120.1 90.08 150.13
L-Glycine 10.6 7.95 13.25
L-Histidine 17.7 13.28 22.13
L-lsoleucine 28.3 21 .23 35.38
L-Leucine 47.7 35.78 59.63
L- Lysine 42.4 31 .80 53.00
L-Methionine 18.3 13.73 22.88
L-Phenylalanine 28.3 21 .23 35.38
L-Proline 5.9 4.43 7.38
L-Serine 33 24.75 41.25
L-Threonine 24.1 18.08 30.13
L-Tryptophan 3.5 2.63 4.38
L-Tyrosine 32.4 24.30 40.50
L-Valine 35.3 26.48 44.13
B
Calcium casseinate 240 180.00 300.00
C
Flavour: Butter
50
F2532/D
Flavour: Chocolate
50
NJ0159D1
Cocoa powder 100
Flavour: Vanilla
10
F544/D
Sweetener HA201 1 1 .4
Xanthan gum 15
Table 10
The third dosage unit may be in an oral dosage form such as a tablet or capsule containing approximately 100mg biotin, approximately 20mg coenzyme Q10, approximately 800mcg folic acid, approximately 10mg pantothenate, approximately 333 IU vitamin A in the form of beta carotene, approximately 24mcg vitamin B1 in the form of methylcobalamin;approximately 4mg vitamin B2, approximately 18mg vitamin B3 in the form of nicotenamid, 10mg of vitamin B2 and approximately 500 IU vitamin D3.
The typical formulation of the third dosage unit is illustrated in table 1 1 .
Figure imgf000029_0001
Table 1 1
The concentration of vitamin D3 will typically be 500 IU per day, however if a genetic variation is discovered in a patient that blocks the activation of vitamin D3, vitamin D2 may be added to the regimen. The concentration of vitamin D2 will typically be 50 000 IU per day until blood levels normalise to 50ng - 100ng. The concentration of vitamin D2 advised may then be reduced to 50 000 IU 3 times per week.
The fourth dosage unit may be in the form of a capsule or tablet containing approximately 120mg alpha lipoic acid, approximately 4mg of 5% extract of astaxanthin, approximately 30mg of grape seed extract, approximately 30mg of resveratrol, approximately 100mg of rooibos teas exteract, approximately 50 mg roship vitamin C, approximately 10mg 0.3% sulforaphane, approximately 1665 IU vitamin A in the form of beta carotene, approximately 15 IU alpha tocopherol and approximately 100 meg elemental L- selenomethionine.
The fourth dosage unit is illustrated in table 12 below.
Figure imgf000030_0001
Table 12
The fifth dosage unit may be a capsule or tablet containing approximately 3mg boron, approximately 100mg calcium, approximately 120 meg chromium in the form of niccotinoglycinate amino acid chelate, approximately 2mg copper, approximately 100mg magnesium as glycinate amino acid chelate or magnesium oxide, approximately 75 meg molybdenum, approximately 100mg potassium in the form of potassium glycinate amino acid complex or potassium gluconate or asparate or citrate or iodide, approximately 15mg zinc in the form of ACC, approximately 100mg salmon oil and approximately 500mg evening primrose oil. The fifth dosage unit is illustrated in table 13 below.
Minerals and Trace elements (Capsule
or Tablet) Values Units Lowest Highest
Boron 3 mg 2.25 3.75
Calcium 100 mg 75.00 125
Chromium 120 meg 90.00 150
Copper 2 mg 1 .50 2.5
Magnesium 100 mg 75.00 125
Figure imgf000031_0001
nc mg . .
Table 13
The sixth dosage unit typically contains 1000mg salmon oil and 500mg evening primrose oil as illustrated in table 14.
Docosahexaenoic (DHA) Units Lowest Highest
Eicosapentaenoic Acid(EPA)
Salmon Oil (Fish Oil) evening 1000 mg 750.00 1250
Container in the box
Evening Primrose Oil evening 500 mg 375.00 625
Table 14
In the case where patients are diagnosed with a mental condition such as depression, additional Salmon Oil may be taken in the morning, the concentration whereof may vary between 500 - 1000 mg. This will be supplied as additional capsules.
A seventh dosage unit consisting of capsules containing Lecithin, may be added if it is not included in the protein shake, or in addition to that which is contained in the protein shake:
Figure imgf000031_0002
The Lecithin may also be supplied as granules to be sprinkled over breakfast cereal.

Claims

CLAIMS:
1 . A kit for use in a method of inhibiting damage or demise of myelin- producing cells, which method comprises administering to a patient in need of such treatment an effective amount of a plurality of nutritional supplements, the kit having a container with a plurality of distinct compartments, each compartment containing a plurality of dosage units of the nutritional supplements, the nutritional supplements constituting sufficient daily multi-unit doses for a period of time.
2. A kit as claimed in claim 1 , in which the nutritional supplements are selected from iron, essential amino acids, lipids, minerals and vitamins.
3. A kit as claimed in either claim 1 or claim 2, in which the kit includes amino acids selected from leucine, isoleucine, lysine, tryptophan, methionine, phenylalanine, threonine, valine and histidine.
4. A kit as claimed in claim 3, in which the kit includes one or more of the following amino acids in the following amounts:
1235mg leucine;
890mg isoleucine;
995mg lysine;
175mg tryptophane;
315mg methionine;
610mg phenylalanine;
570mg threonine;
840mg valine; and
340mg histidine.
5. A kit as claimed in any one of the preceding claims, in which the kit includes lipids selected from evening primrose oil, salmon oil and lecithin.
6. A kit as claimed in claim 5, in which the kit includes one or more of the following lipids in the following amounts:
approximately 500mg evening primrose oil;
approximately 500mg salmon oil; and
approximately 300mg lecithin.
7. A kit as claimed in any one of the preceding claims, in which the kit includes vitamins selected from beta carotene, vitamin C, vitamin E, vitamin B1 , vitamin B2, nicotinamide, folic acid, vitamin B12, vitamin B6, pantothenate, vitamin D2 and vitamin D3.
8. A kit as claimed in claim 7, in which the kit includes one or more of the following vitamins in the following amounts:
3mg beta carotene;
350mg vitamin C;
40mg vitamin E;
3mg vitamin B1 ;
4mg vitamin B2;
20mg nicotinaminde;
24μg vitamin B12;
10mg vitamin B6;
10mg panthothenate;
50 000 IU vitamin D2; and
500 IU vitamin D3.
9. A kit as claimed in any one of the preceding claims, in which the kit includes minerals selected from calcium, magnesium, copper, zinc, manganese, chromium, molybdenum and selenium.
10. A kit as claimed in claim 9, in which the kit includes one or more of the following minerals in the following amounts:
28.5mg calcium;
150mg magnesium;
1 mg copper;
15mg zinc;
2.5mg manganese;
10C^g chromium;
100μg molybdenum; and
6C^g selenium.
1 1 . A kit as claimed in any one of the preceding claims, in which the kit includes 1235mg leucine, 890mg isoleucine, 995mg lysine, 175mg tryptophan, 3154mg methionine, 610mg phenylalanine, 570mg threonine, 840mg valine, 340mg histidine, 3mg beta carotene, 350mg vitamin C, 40mg vitamin E, 3mg vitamin B1 , 4mg vitamin B2, 20mg nicotinamide, 5mg folic acid, 24 μg vitamin B12, 10mg vitamin B6, 10mg pantothenate, 50 000 IU mg vitamin D2, 500 IU vitamin D3, 28.5mg calcium, 150mg magnesium, 1 mg copper, 15mg zinc, 2,5mg manganese, 100μg chromium, 100μg molybdenum and 60μg selenium and optionally 15mg iron.
12. A kit as claimed in any one of the preceding claims, in which the nutritional supplements are oral dosage forms selected from tablets, capsules, fluids, powders and dietary shakes.
13. A kit as claimed in claim 12, in which one or more of the dosage forms include two or more of the nutritional supplements.
14. A kit as claimed in any one of the preceding claims, in which the kit contains multiple dosage units of the same nutritional supplement.
15. A kit as claimed in any one of claims 1 to 13, in which the kit has at least 28 compartments containing a daily dosage unit of each of the different nutritional supplements.
16. A kit as claimed in any one of the preceding claims, in which each of the compartments has a separate cap.
17. A kit as claimed in claim 16, in which the kit has at least one lid covering the compartments and corresponding caps.
18. A nutritional composition for use in a method of inhibiting damage or demise of myelin-producing cells, which method comprises administering to a patient in need of such treatment an effective amount of a plurality of nutritional supplements; the supplements being selected from iron, essential amino acids, lipids, minerals and vitamins.
19. A nutritional composition as claimed in claim 18, in which the amino acids are selected from leucine, isoleucine, lysine, tryptophan, methionine, phenylalanine, threonine, valine and histidine.
20. A nutritional composition as claimed in either one of claims 18 or 19, in which the nutritional composition includes one or more amino acids in the following amounts:
1235mg leucine;
890mg isoleucine;
995mg lysine;
175mg tryptophane;
315mg methionine;
610mg phenylalanine;
570mg threonine;
840mg valine; and
340mg histidine.
21 . A nutritional composition as claimed any one of claims 18 to 20, in which the lipids are selected from evening primrose oil, salmon oil and lecithin.
22. A nutritional composition as claimed in any one of claims 18 to 21 , in which the nutritional composition includes one or more lipids in the following amounts:
about 500mg evening primrose oil; about 500mg salmon oil;
about 300mg lecithin.
23. A nutritional composition as claimed in any one of claims 18 to 22, in which the vitamins are selected from beta carotene, vitamin C, vitamin E, vitamin B1 , vitamin B2, nicotinamide, folic acid, vitamin B12, vitamin B6, pantothenate, vitamin D2 and vitamin D3.
24. A nutritional composition as claimed in any one claims 18 to 23, in which the nutritional composition includes one or more vitamins in the following amounts:
3mg beta carotene;
350mg vitamin C;
40mg vitamin E;
3mg vitamin B1 ;
4mg vitamin B2;
20mg nicotinamide;
24μg vitamin B12;
10mg vitamin B6;
10mg panthothenate;
50 000 IU vitamin D2; and
500 IU vitamin D3;
25. A nutritional composition as claimed in any one of claims 18 to 24, in which the minerals are selected from calcium, magnesium, copper, zinc, manganese, chromium, molybdenum and selenium.
26. A nutritional composition as claimed in any one of claims 18 to 25, in which the nutritional composition includes one or more minerals in the following amounts:
28.5mg calcium;
150mg magnesium;
1 mg copper;
15mg zinc;
2.5mg manganese;
100μg chromium; 100μ9 molybdenum; and
60μ9 selenium.
27. A nutritional composition as claimed in any one claims 18 to 26, in which the nutritional composition comprises 1235mg leucine, 890mg isoleucine, 995mg lysine, 175mg tryptophan, 3154mg methionine, 610mg phenylalanine, 570mg threonine, 840mg valine, 340mg histidine, 3mg beta carotene, 350mg vitamin C, 40mg vitamin E, 3mg vitamin B1 , 4mg vitamin B2, 20mg nicotinamide, 5mg folic acid, 24 μg vitamin B12, 10mg vitamin B6, 10mg pantothenate, 50 000 IU mg vitamin D2, 500 IU vitamin D3, 28.5mg calcium, 150mg magnesium, 1 mg copper, 15mg zinc, 2,5mg manganese, 100μg chromium, 100μg molybdenum and 60μg selenium and optionally 15mg iron.
28. A nutritional composition as claimed in any one of the claims 18 to 27, in which the nutritional supplements are contained in a plurality of dosage units.
29. A nutritional composition as claimed in claim 28, in which the dosage units are oral dosage forms selected from tablets, capsules, fluids, powders and dietary shakes.
30. A nutritional composition as claimed in either claim 28 or claim 29, in which one or more of the dosage units contains two or more of the nutritional supplements.
PCT/IB2013/058945 2012-09-28 2013-09-27 Nutritional kit WO2014049566A2 (en)

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IT201900025069A1 (en) * 2019-12-20 2021-06-20 Alidans S R L ORAL COMPOSITION TO PROMOTE THE REGENERATION OF PERIPHERAL NERVES

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IT201800005508A1 (en) * 2018-05-18 2019-11-18 Kit for use as a food supplement in the treatment of vitamin and / or mineral deficiencies in pediatrics.
IT201900025069A1 (en) * 2019-12-20 2021-06-20 Alidans S R L ORAL COMPOSITION TO PROMOTE THE REGENERATION OF PERIPHERAL NERVES

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