Method for treatment and prevention of deficiencies of vitamins B12, folic acid, and B6

• US 6,207,651 B1
• Filed: 01/26/1998
• Issued: 03/27/2001
• Est. Priority Date: 08/02/1996
• Status: Expired due to Fees

• Current Assignee: Metabolite Laboratories Incorporated
• Original Assignee: Metabolite Laboratories Incorporated
• Inventors: Allen, Robert H., Stabler, Sally P.
• Primary Examiner(s): Peselev, Elli
• Application Number:
  US09/012,955
• Time in Patent Office: 1,156 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 31/525 Isoalloxazines, e.g. riboflavins, vitamin B2
• 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 vascular disease in a human, 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 vascular disease is cardiovascular disease.

4. The method of claim 1 wherein said vascular disease is stroke.

5. The method of claim 1 wherein said vascular disease is peripheral vascular disease.

6. The method of claim 1 wherein said vascular disease is associated with renal disease.

7. A method of treating vascular disease in a human, 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 vascular disease is cardiovascular disease.

10. The method of claim 7 wherein said vascular disease is stroke.

11. The method of claim 7 wherein said vascular disease is peripheral vascular disease.

12. The method of claim 7 wherein said vascular disease is associated with renal disease.

13. A method of treating vascular disease in a human, 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 vascular disease is cardiovascular disease.

16. The method of claim 13 wherein said vascular disease is stroke.

17. The method of claim 13 wherein said vascular disease is peripheral vascular disease.

18. The method of claim 13 wherein said vascular disease is associated with renal disease.

19. A method of treating vascular disease in a human, 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 vascular disease is cardiovascular disease.

22. The method of claim 19 wherein said vascular disease is stroke.

23. The method of claim 19 wherein said vascular disease is peripheral vascular disease.

24. The method of claim 19 wherein said vascular disease is associated with renal disease.