Method for treatment and prevention of deficiencies of vitamins B.sub.12, folic acid and B.sub.6

• US 5,795,873 A
• Filed: 08/02/1996
• Issued: 08/18/1998
• Est. Priority Date: 12/29/1992
• Status: Expired due to Term

• Current Assignee: Metabolite Laboratories Incorporated
• Original Assignee: Metabolite Laboratories Incorporated
• Inventors: Allen, Robert H.
• Primary Examiner(s): Scheiner, Laurie
• Assistant Examiner(s): Parkin, Jeffrey S.
• Application Number:
  US08/693,515
• Time in Patent Office: 746 Days
• Field of Search: 514/52, 514/249, 514/345, 514/814
• US Class Current: 514/52
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/505 Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
• CPC Class Codes: A61K 31/714 Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12

Abstract

A method for orally administering vitamin preparations is described which combine vitamin B₁₂ (B₁₂, cobalamin) and folic acid (folate), with and without pyridoxine (B₆), for preventing and treating elevated serum homocysteine (HC), cystathionine (CT), methylmalonic acid (MMA), or 2-methylcitric acid (2-MCA) levels. These metabolites have been shown to be indicative of B₁₂ and/or folic acid deficiencies. Further, it is likely that a B₆ deficiency may be present with a B₁₂ or folate deficiency. The method of the invention is also for use in lowering serum HC, CT, MMA, or 2-MCA in patients with or at risk for neuropsychiatric, vascular, renal or hematologic diseases. One embodiment of the invention is the use of a non-prescription formulation containing 2.0 mg B₁₂ and 0.4 mg folic acid, with and without 25 mg B₆. Another embodiment uses a prescription strength formulation containing 2.0 mg B₁₂ and 1.0 mg folic acid, with and without 25 mg B₆. The method of the present invention eliminate the costly and time consuming steps of distinguishing between vitamin deficiencies once a deficiency is found by measurement of serum metabolite levels. The present invention is of particular benefit to the populations at risk for elevated serum metabolite levels, such as the people over the age of 65, and populations that have or are at risk for neuropsychiatric, vascular, renal and hematologic diseases.

Claims

1. A method of treating or preventing elevated serum metabolite levels of at least one of homocysteine, methylmalonic acid, cystathionine, or 2-methylcitric acid comprising periodically administering orally a single formulation having between 0.3-10 mg vitamin B₁₂ and 0.1-0.4 mg folic acid.

2. The method of claim 1 wherein the formulation includes approximately 2 mg vitamin B₁₂ and 0.4 mg folic acid.

3. The method of claim 1 wherein said metabolite is homocysteine.

4. The method of claim 1 wherein said metabolite is methylmalonic acid.

5. The method of claim 1 wherein said metabolite is cystathionine.

6. The method of claim 1 wherein said metabolite is 2-methylcitric acid.

7. A method of treating or preventing elevated serum metabolite levels of at least one of homocysteine, methylmalonic acid, cystathionine, or 2-methylcitric acid comprising periodically administering orally a single formulation having between 0.3-10 mg vitamin B₁₂, 0.1-0.4 mg folic acid, and 5-75 mg B₆.

8. The method of claim 7 wherein the formulation includes approximately 2 mg vitamin B₁₂ and 0.4 mg folic acid and 25 mg B₆.

9. The method of claim 7 wherein said metabolite is homocysteine.

10. The method of claim 7 wherein said metabolite is methylmalonic acid.

11. The method of claim 7 wherein said metabolite is cystathionine.

12. The method of claim 7 wherein said metabolite is 2-methylcitric acid.

13. A method of treating or preventing elevated serum metabolic levels of at least one of homocysteine, methylmalonic acid, cystathionine, or 2-methylcitric acid comprising periodically administering orally a single formulation having between 0.3-10 mg vitamin B₁₂ and 0.4-10.0 mg folic acid.

14. The method of claim 13 wherein the formulation includes approximately 2 mg vitamin B₁₂ and 1.0 mg folic acid.

15. The method of claim 13 wherein said metabolite is homocysteine.

16. The method of claim 13 wherein said metabolite is methylmalonic acid.

17. The method of claim 13 wherein said metabolite is cystathionine.

18. The method of claim 13 wherein said metabolite is 2-methylcitric acid.

19. A method of treating or preventing elevated serum metabolite levels of at least one of homocysteine, methylmalonic acid, cystathionine, or 2-methylcitric acid comprising periodically administering orally a single formulation having between 0.3-10 mg vitamin B₁₂, 0.4-10 mg folic acid, and 5-75 mg B₆.

20. The method of claim 19 wherein the formulation includes approximately 2 mg vitamin B₁₂ and 1.0 mg folic acid and 25 mg B₁₂.

21. The method of claim 19 wherein said metabolite is homocysteine.

22. The method of claim 19 wherein said metabolite is methylmalonic acid.

23. The method of claim 19 wherein said metabolite is cystathionine.

24. The method of claim 19 wherein said metabolite is 2-methylcitric acid.

25. A method of lowering serum metabolite levels of at least one of homocysteine, methylmalonic acid, cystathionine, or 2-methylcitric acid comprising periodically administering orally a single formulation having between 0.3-10 mg vitamin B₁₂, 0.1-0.4 mg folic acid.

26. A method of claim 25 wherein the formulation includes approximately 2 mg vitamin B₁₂ and 0.4 mg folic acid.

27. The method of claim 25 wherein said metabolite is homocysteine.

28. The method of claim 25 wherein said metabolite is methylmalonic acid.

29. The method of claim 25 wherein said metabolite is cystathionine.

30. The method of claim 25 wherein said metabolite is 2-methylcitric acid.

31. A method of lowering serum metabolite levels of at least one of homocysteine, methylmalonic acid, cystathionine, or 2-methylcitric acid comprising periodically administering orally a single formulation having between 0.3-10 mg vitamin B₁₂, 0.1-0.4 mg folic acid, and 5-75 mg B₆.

32. The method of claim 31 wherein the formulation includes approximately 2 mg vitamin B₁₂ and 0.4 mg folic acid and 25 mg B₆.

33. The method of claim 31 wherein said metabolite is homocysteine.

34. The method of claim 31 wherein said metabolite is methylmalonic acid.

35. The method of claim 31 wherein said metabolite is cystathionine.

36. The method of claim 31 wherein said metabolite is 2-methylcitric acid.

37. A method of lowering serum metabolite levels of at least one of homocysteine, methylmalonic acid, cystathionine, or 2-methylcitric acid comprising periodically administering orally a single formulation having between 0.3-10 mg vitamin B₁₂ and 0.4-10.0 mg folic acid.

38. The method of claim 37 wherein the formulation includes approximately 2 mg vitamin B₁₂ and 1.0 mg folic acid.

39. The method of claim 37 wherein said metabolite is homocysteine.

40. The method of claim 37 wherein said metabolite is methylmalonic acid.

41. The method of claim 37 wherein said metabolite is cystathionine.

42. The method of claim 37 wherein said metabolite is 2-methylcitric acid.

43. A method of lowering serum metabolite levels of at least one of homocysteine, methylmalonic acid, cystathionine, or 2-methylcitric acid comprising periodically administering orally a single formulation having between 0.3-10 mg vitamin B₁₂, 0.4-10 mg folic acid, and 5-75 mg B₆.

44. The method of claim 43 wherein the formulation includes approximately 2 mg vitamin B₁₂ and 1.0 mg folic acid and 25 mg B₆.

45. The method of claim 43 wherein said metabolite is homocysteine.

46. The method of claim 43 wherein said metabolite is methylmalonic acid.

47. The method of claim 43 wherein said metabolite is cystathionine.

48. The method of claim 43 wherein said metabolite is 2-methylcitric acid.