Compositions, kits and methods for nutrition supplementation

Abstract

A method for improving a nutritional status in a prenatal, pregnant or breastfeeding patient. The method includes providing a pharmaceutical composition in a single oral dosage form for administration to a prenatal, pregnant or breastfeeding patient. The pharmaceutical composition consists of vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega-3 fatty acids and one or more pharmaceutically acceptable carriers. The method further includes providing a daily dosage regimen for administering the single oral dosage form to the patient to improve a nutritional status in the patient.

1 . A method for improving a nutritional status in a prenatal, pregnant or breastfeeding patient, the method comprising:
 providing a pharmaceutical composition in a single oral dosage form for administration to a prenatal, pregnant or breastfeeding patient, the pharmaceutical composition consisting of: vitamin D in an amount of about 500 I.U. to about 1500 I.U., iodine in an amount of about 75 μg to about 225 μg, vitamin B1 in an amount of about 0.8 mg to about 2.4 mg, vitamin B6 in an amount of about 1.2 mg to about 3.8 mg, vitamin B12, vitamin B2 in an amount of about 0.9 mg to about 2.7 mg, vitamin B9 in an amount of about 0.5 mg to about 1.5 mg, vitamin B3 in an amount of about 7.5 mg to about 22.5 mg, vitamin E in an amount of about 10 I.U. to about 30 I.U., vitamin A in an amount of about 550 I.U. to about 1650 I.U., vitamin C, iron, zinc in an amount of about 12.5 mg to about 37.5 mg, copper in an amount of about 1.0 mg to about 3.0 mg, magnesium in an amount of about 10 mg to about 30 mg, omega-3 fatty acids in an amount of about 100 mg to about 300 mg and one or more pharmaceutically acceptable carriers; and   providing a daily dosage regimen for administering the single oral dosage form to the patient to improve a nutritional status in the patient.   
     
     
         2 . The method of  claim 1 , wherein the single oral dosage form is selected from the group consisting of: a capsule, tablet, caplet, gelcap, syrup, a liquid composition, a powder, a concentrated powder, a concentrated powder admixed with a liquid, a chewable form, a swallowable form, a dissolvable form, an effervescent, a granulated form, and an oral liquid solution. 
     
     
         3 . The method of  claim 2 , wherein the single oral dosage form is a gelcap. 
     
     
         4 . The method of  claim 3 , wherein the daily dosage regimen is one gelcap daily. 
     
     
         5 . The method of  claim 1 , wherein compliance with the daily dosage regimen in the patient is improved over a 6 month period of administration. 
     
     
         6 . The method of  claim 1 , wherein the nutritional status of the patient is improved after a 6 month period of administration. 
     
     
         7 . The method of  claim 6 , wherein the improvement in the nutritional status of the patient is an improvement in at least one of the vitamin, mineral and nutrient levels of the patient. 
     
     
         8 . The method of  claim 6 , wherein the improvement in the nutritional status of the patient is an unelevated homocysteine serum level in the patient. 
     
     
         9 . The method of  claim 1 , wherein said vitamin D is in the form selected from one or more of the group consisting of vitamin D3, vitamin D2, previtamin D2, ergosterol, calcitriol, 7-dehydrocholesterol, Vitamin D1, vitamin D4, vitamin, 7-dehydrositosterol, Lumisterol, 25-hydroxyvitamin D, all steroids that exhibit the biological activity of calciol, 25-fluorocalciol, (3S)-3-amino-3-deoxycalciol, 11α-acetoxycalciol, calcidiol, ercalcitriol, calcitetrol, tacalciol, (5E)-isocalciol, Dihydroercalciol, (1S)-Hydroxycalciol, (24R)-Hydroxycalcidiol, Ercalcidiol, Ercalcitriol, Ertacalciol, (5E)-(10S)-10,19-Dihydroercalciol, (6Z)-Tacalciol, and (22E)-(24R)-Ethyl-22,23-didehydrocalciol;
 wherein said vitamin B1 is in the form selected from one or more of the group consisting of thiamine, thiamine mononitrate, thiamine monophosphate, thiamine diphosphate, thiamine triphosphate, acetiamine, allithiamine, prosultiamine and S-acyl derivatives of thiamine, including benfotiamine, fursultiamine and salts and esters thereof; 
 wherein said vitamin A is in the form selected from one or more of the group consisting of retinol acetate, retinol, retinol palmitate, retinoic acid, retinal, beta-cryptoxanthin, alpha-carotene, beta-carotene, gamma-carotene, and provitamin A carotenoids; 
 wherein said vitamin B9 is in the form selected from one or more of the group consisting of folic acid, folinic acid, folacin, metafolin, and/or one or more natural isomers of folate including (6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, (6S,R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-methyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-methyl-(6S,R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-formyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 10-formyl-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5,10-methylene-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5,10-methenyl-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof and 5-formimino-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof and their salts and esters thereof; 
 wherein said vitamin B2 is in the form selected from one or more of the group consisting of flavin mononucleotide (FMN), flavin adenine dinucleotide (FAD), riboflavin (also known as 7,8-dimethyl-10-((2R,3R,4S)-2,3,4,5-tetrahydroxypentyl) benzo[g]pteridine-2,4 (3H,10H)-dione or lactoflavin) and riboflavin derivatives, including riboflavin-5′-monophosphate, riboflavin-5′-monobutyrate and riboflavin-5′-monopalmitate; 
 wherein said vitamin B3 is in the form selected from one or more of the group consisting of niacin, and nicotinamide and salts and esters thereof; 
 wherein said vitamin B6 is in the form selected from one or more of the group consisting of pyridoxine, 3-hydroxy-4,5-bis(hydroxymethyl)2-methylpyridine, 5′-deoxypyridoxal, 2-demethylpyridoxal(2-norpyridoxal), 2-propyl-2-norpyridoxal (2′-ethylpyridoxal), 6-methylpyridoxal, 2′-hydroxypyridoxal (2-hydroxymethyl-2-demethylpyridoxal or 2-hydroxymethyl-2-norpyridoxal), 4′-deoxypyridoxine 5′-phosphate, 5′-methylpyridoxal-5′-phosphate, pyridoxal N-oxide 5′-phosphate, Pyridoxal, Pyridoxamine, Pyridoxine-5′-phosphate (PNP), pyridoxal-5′-phosphate (PLP) and pyridoxamine-5′-phosphate (PMP), and their salts and chelates thereof; 
 wherein said vitamin B12 is in the form selected from one or more of the group consisting of cobalamin, methylcobalamin, 5′-deoxyadenosylcobalamin, cyanocobalamin, hydroxycobalamin and mecobalamin; 
 wherein said vitamin E is in the form selected from one or more of the group consisting of alpha, beta, gamma, and delta tocopherols in its natural or synthetic (dl) forms; alpha, beta, gamma, and delta tocotrienols in its natural or synthetic (dl) forms, dl-alpha tocopheryl derivatives, including dl-alpha tocopheryl esters, dl-alpha-tocopheryl acetate or succinate and d-alpha-tocopheryl acetate or dl-alpha tocopheryl phosphates; 
 wherein said vitamin C is in the form selected from one or more of the group consisting of ascorbic acid, asorbates, calcium ascorbate, sodium ascorbate, dehydroascorbic acid and salts, ascorbyl palmitate, ascorbyl phosphates and salts, ascorbyl sulfates and salts, acylated ascorbic acid derivatives, 6-bromo-6-deoxy-L-ascorbic acid, and ascorbate salts; 
 wherein said iron is in the form selected from one or more of the group consisting of elemental iron, in the form of a salt, chelated form, non-chelated form, chelated to an amino acid, carbonyl iron, ferrous gluconate, ferrous fumarate, polysaccharide iron complex, elemental polysaccharide iron, polysaccharide iron, ferrous (II)-bis-glycinate chelate, ferrous asparto glycinate, ferrous bisglycinate, ferrous bisglycinate hydrochloride, ferrous bisglycinate, elemental ferrous bisglycinate, ferrous sulfate, ferronyl (micronized), iron protein succinylate, carbonyl iron, Sumalate iron, Heme iron complex, as Ferrochel amino acid chelate, Heme iron polypeptide as Proferrin-bovine source, as heme iron polypeptide (bovine source) as sodium iron EDTA (Ferrazone), ferric ammonium citrate, elemental iron, and ferric pyrophosphate; 
 wherein said zinc is in the form selected from one or more of the group consisting of elemental zinc, in the form of a salt, in a chelated form, in a non-chelated form, zinc acetate, zinc gluconate, zinc picolinate, zinc sulfate and zinc oxide; 
 wherein said copper is in the form selected from one or more of the group consisting of elemental copper, in the form of a salt, in a chelated form, in a non-chelated form, cupric oxide, copper sulfate, copper gluconate, copper citrate, cupric acetate, and alkaline copper carbonate; 
 wherein said magnesium is in the form selected from one or more of the group consisting of elemental magnesium, in the form of a salt, in a chelated form, in a non-chelated form, magnesium acetate, magnesium carbonate, magnesium gluconate, magnesium chloride, magnesium citrate, magnesium silicate, magnesium stearate, magnesium sulfate, magnesium oxide, and magnesium chelated to an amino acid; 
 wherein said omega 3 fatty acids is in the form selected from one or more of the group consisting docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and α-linolenic acid (ALA); and 
 wherein said iodine is in the form selected from one or more of the group consisting of iodide, elemental iodine, iodized salt, Lugol's iodine, sodium iodide, potassium iodide, potassium iodate, nascent iodine, and Nano-Colloidal Detoxified Iodine. 
 
     
     
         10 . The method of  claim 1 , wherein said vitamin D is in the form of vitamin D3 and is present in an amount of about 1000 I.U. or 25 μg. 
     
     
         11 . The method of  claim 1 , wherein said iodine is present in an amount of about 150 μg. 
     
     
         12 . The method of  claim 1 , wherein said vitamin B1 is present in an amount of about 1.6 mg. 
     
     
         13 . The method of  claim 1 , wherein said vitamin B6 is present in an amount of about 2.5 mg. 
     
     
         14 . The method of  claim 1 , wherein said vitamin B12 is present in an amount of about 12 μg. 
     
     
         15 . The method of  claim 1 , wherein said vitamin B2 is present in an amount of about 1.8 mg. 
     
     
         16 . The method of  claim 1 , wherein said vitamin B9 is present in an amount of about 1.0 mg. 
     
     
         17 . The method of  claim 1 , wherein said vitamin E is present in an amount of about 20 I.U. 
     
     
         18 . The method of  claim 1 , wherein said vitamin A is in the form of beta carotene and is present in an amount of about 1100 I.U. or about 660 μg. 
     
     
         19 . The method of  claim 1 , wherein said vitamin C is present in an amount of about 30 mg. 
     
     
         20 . The pharmaceutical composition of  claim 1 , wherein said vitamin B3 is in the form of nicotinamide and is present in an amount of about 15 mg. 
     
     
         21 . The method of  claim 1 , wherein said iron is present in an amount of about 29 mg. 
     
     
         22 . The method of  claim 1 , wherein said zinc is present in an amount of about 25 mg. 
     
     
         23 . The method of  claim 1 , wherein said copper is present in an amount of about 2.0 mg. 
     
     
         24 . The method of  claim 1 , wherein said magnesium is present in an amount of about 20 mg. 
     
     
         25 . The method of  claim 1 , wherein said omega 3 fatty acids comprises DHA and is present in an amount of about 200 mg. 
     
     
         26 . The method of  claim 1 , wherein said omega-3 fatty acids comprises DHA, and wherein the source of DHA is algae oil. 
     
     
         27 . The method of  claim 26 , wherein the source of the algae oil is microalgae  Crypthecodinium cohnii.    
     
     
         28 . The method of  claim 1 , wherein said pharmaceutically acceptable carriers include one or more selected from the group consisting of gelatin, sorbitol, glycerin, soybean oil, beeswax, dicalcium phosphate, lecithin oil, vegetable oil, and colorants. 
     
     
         29 . The method of  claim 1 , wherein said composition does not contain fish oils. 
     
     
         30 . The method of  claim 1 , wherein said vitamin B12 is present in an amount of about 6 μg to about 18 μg. 
     
     
         31 . The method of  claim 1 , wherein said vitamin C is present in an amount of about 15 mg to about 45 mg. 
     
     
         32 . The method of  claim 1 , wherein said iron is present in an amount of about 14.5 mg to about 43.5 mg.