Compositions comprising choline

Abstract

The present disclosure provides a single dose form composition to optimize the relationship between the ‘Tolate-Cobalamin’ and ‘Choline-Betaine’ pathways. Single dose form compositions disclosed herein ensure an adequate intake of the rate limiting compounds that have been demonstrated to reduce the efficiency of this vital metabolic axis, and methods of use thereof.

What is claimed is: 
     
         1 . A method for supplementing iron to a human subject, the method comprising administering to the subject a single dosage form composition comprising (a) iron in a form of one or more physiologically acceptable iron compounds, chelates, complexes, or admixtures, and in a total elemental iron amount of about 10 mg to about 150 mg; and (b) choline in a form of one or more physiologically acceptable salts, phospholipid bound forms, intermediates or derivatives thereof, and in a total amount of choline molecule of at least 50 mg to about 5000 mg, wherein the subject has (i) iron deficiency and (ii) either an increased risk for, or is diagnosed with, non-alcoholic fatty liver disease, metabolic syndrome, or type 2 diabetes mellitus. 
     
     
         2 . The method of  claim 1 , wherein the composition further comprises intrinsic factor in an amount of about 35 μg to about 10,000 μg. 
     
     
         3 . The method of  claim 2 , wherein the composition comprises intrinsic factor in an amount of about 35 μg to about 950 μg 
     
     
         4 . The method of  claim 2 , wherein the intrinsic factor comprises a recombinant human intrinsic factor (rhIF) or a rhIF-B 12  complex. 
     
     
         5 . The method of  claim 1 , wherein the total amount of elemental iron is about 40 mg to about 150 mg. 
     
     
         6 . The method of  claim 1 , wherein the total amount of elemental iron is about 50 mg to about 150 mg. 
     
     
         7 . The method of  claim 1 , wherein the total amount of elemental iron is about 20 mg to about 70 mg. 
     
     
         8 . The method of  claim 1 , wherein the total amount of elemental iron is about 30 mg to about 60 mg. 
     
     
         9 . The method of  claim 1 , wherein the iron is an iron amino acid chelate. 
     
     
         10 . The method of  claim 9 , wherein the iron amino acid chelate is ferrous asparto glycinate or ferrous bisglycinate. 
     
     
         11 . The method of  claim 1 , wherein the iron is ferric glycinate. 
     
     
         12 . The method of  claim 1 , wherein the total amount of choline molecule is about 75 mg to about 1500 mg. 
     
     
         13 . The method of  claim 1 , wherein the choline is choline bitartrate. 
     
     
         14 . The method of  claim 1 , wherein the choline is choline chloride. 
     
     
         15 . The method of  claim 1 , wherein the choline is choline dihydrogen citrate. 
     
     
         16 . The method of  claim 1 , wherein the human subject also has an increased risk for, or is diagnosed with, hepatocellular carcinogenesis, colonic neoplasia, colorectal carcinogenesis, atherosclerosis, or dysmetabolic iron overload syndrome. 
     
     
         17 . The method of  claim 1 , wherein the administration comprises administering the single dosage form once per day for about seven days. 
     
     
         18 . The method of  claim 1 , wherein the administration comprises administering the single dosage form once per day for about twenty-one days. 
     
     
         19 . The method of  claim 18 , wherein the administration further comprises discontinuing the administration for about seven days prior to again initiating the administration. 
     
     
         20 . A method for supplementing iron to a human subject, the method comprising administering to the subject a single dosage form composition comprising (a) iron in a form of one or more physiologically acceptable iron compounds, chelates, complexes, or admixtures, and in a total elemental iron amount of about 10 mg to about 150 mg; and (b) choline in a form of one or more physiologically acceptable salts, phospholipid bound forms, intermediates or derivatives thereof, and in a total amount of choline molecule of at least 50 mg to about 5000 mg, and (c) intrinsic factor in an amount of about 35 μg to about 10,000 μg, wherein the subject has (i) iron deficiency and (ii) either an increased risk for, or is diagnosed with, non-alcoholic fatty liver disease, metabolic syndrome, or type 2 diabetes mellitus.