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 - 32 . (canceled) 
     
     
         33 . A method for improving a nutritional status in a prenatal, pregnant or breastfeeding patient, the method comprising:
 administering to the prenatal, pregnant or breastfeeding patient, a single oral dosage form of a pharmaceutical composition consisting of:   vitamin D in an amount of about 400 I.U. to about 1600 I.U.,   vitamin B1 in an amount of about 0.8 mg to about 2.4 mg,   vitamin B6   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,   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,   optionally iodine in an amount of about 75 μg to about 225 μg,   optionally magnesium in an amount of about 10 mg to about 30 mg,   optionally omega-3 fatty acids in an amount of about 100 mg to about 300 mg and   one or more pharmaceutically acceptable carriers;   wherein the single oral dosage form is administered in a daily dosage regimen to the prenatal, pregnant or breastfeeding patient and improves the nutritional status in the prenatal, pregnant or breastfeeding patient.   
     
     
         34 . The method of  claim 33 , wherein the single oral dosage form consists of:
 vitamin D in an amount of about 400 I.U. to about 1600 LU.,   vitamin B1 in an amount of about 0.8 mg to about 2.4 mg,   vitamin B6   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,   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,   iodine in an amount of about 75 μg to about 225 μg,   magnesium in an amount of about 10 mg to about 30 mg, and   omega-3 fatty acids in an amount of about 100 mg to about 300 mg and   one or more pharmaceutically acceptable carriers;   
     
     
         35 . The method of  claim 33 , wherein the single oral dosage form is a chewable form. 
     
     
         36 . The method of  claim 33 , wherein the single oral dosage form is a tablet or capsule. 
     
     
         37 . The method of  claim 33 , 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. 
     
     
         38 . The method of  claim 33 , wherein the improvement in the nutritional status of the patient is an unelevated homocysteine serum level in the patient. 
     
     
         39 . The method of  claim 33 ,
 wherein said vitamin D is in the form of vitamin D3;   wherein said vitamin B 1 is in the form selected from one or more of the group consisting of thiamine, thiamine mononitrate, thiamine monophosphate, thiamine diphosphate, and thiamine triphosphate;   wherein said vitamin A is in the form selected from one or more of the group consisting of retinol acetate, retinol, retinol palmitate, alpha-carotene, beta-carotene, and gamma-carotene;   wherein said vitamin B9 is in the form selected from one or more of folic acid and folate;   wherein said vitamin B2 is in the form of riboflavin;   wherein said vitamin B3 is in the form selected from one or more of the group consisting of niacin and nicotinamide;   wherein said vitamin B6 is in the form of pyridoxine or a salt thereof;   wherein said vitamin B12 is in the form of cyanocobalamin;   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;   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 acids, 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, 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, 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; and   wherein said pharmaceutically acceptable carrier is selected from one or more of the group consisting of diluents, lubricants and glidants.   
     
     
         40 . The method of  claim 33 ,
 wherein said vitamin D is in the form of vitamin D3;   wherein said vitamin B1 is in the form of thiamine mononitrate;   wherein said vitamin A is in the form selected from one or more of the group consisting of retinol acetate and beta-carotene;   wherein said vitamin B9 is in the form of folate;   wherein said vitamin B2 is in the form of riboflavin;   wherein said vitamin B3 is in the form of nicotinamide;   wherein said vitamin B6 is in the form of pyridoxine or a salt thereof;   wherein said vitamin B12 is in the form of cyanocobalamin;   wherein said vitamin E is in the form selected from one or more of the group consisting of alpha tocopherols in its natural or synthetic (dl) forms;   wherein said vitamin C is in the form of ascorbic acid;   wherein said iron is in the form of ferrous fumarate;   wherein said zinc is in the form of zinc oxide;   wherein said copper is in the form of cupric oxide; and   wherein said pharmaceutically acceptable carrier is selected from one or more of the group consisting of diluents, lubricants and glidants.   
     
     
         41 . The method of  claim 33 , wherein said vitamin D is present in an amount of about 900 I.U. to about 1100 I.U. 
     
     
         42 . The method of  claim 33 , wherein said zinc is present in an amount of about 25 mg. 
     
     
         43 . The method of  claim 33 , wherein said copper is present in an amount of about 2.0 mg.