Method for preventing vascular disease

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. The method of the present invention eliminates 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.

Description

[0001] This application is a continuation of Ser. No. 09 / 793,214, filed on Feb. 26, 2001, which is a continuation of Ser. No. 09 / 273,754 filed Mar. 22, 1999, now issued as U.S. Pat. No. 6,297,224, which is a continuation of application no. Ser. No. 09 / 012,955 filed Jan. 26, 1998 now issued as U.S. Pat. No. 5,795,873, which is a divisional of application no. Ser. No. 07 / 999,499, which was filed Dec. 29, 1992, now issued as U.S. Pat. No. 5,563,126.FIELD OF THE INVENTION [0002] This invention relates to the field of nutrition. Specifically, the invention is comprised of new oral vitamin preparations combining vitamin B12 (B12, cobalamin) and folic acid (folate), and vitamin B12, folate, and pyridoxine (B6) for use in patients with elevated serum metabolite levels of homocysteine (HC), cystathionine (CT), methylmalonic acid (MMA), or 2-methylcitric acid (2-MCA). The elevation of these metabolites has been shown to be indicative of tissue deficiencies of B12 and / or folate and / or B6, and ...

AI Technical Summary

Benefits of technology

The combination of B12, folate, and B6 in oral formulations effectively normalizes serum metabolite levels, simplifies diagnosis, and reduces treatment costs and time, addressing the limitations of traditional methods by targeting tissue deficiencies directly.

Problems solved by technology

While it has been well recognized that individuals with B12 deficiency could display neurologic disorders in the absence of anemia, such situations were believed to be exceptional and rare.

The theory also implies that moderate elevations of HC might be associated with increased risk for vascular disease (Ueland et al.

It is also likely that such heterozygotes are also at increased risk for vascular disease and thrombosis after age 50.

It is difficult, expensive and time-consuming to distinguish between deficiencies of vitamins B12, folate, and B6.

Similarly to a B12 deficiency, B6 deficiencies also result in hematologic as well as neuropsychiatric abnormalities.

The traditional methods of determining deficiencies by measurement of serum vitamin levels are often insensitive.

This method of treatment is both expensive and time-consuming.

In the presence of multiple deficiencies, the diagnosis of vitamin deficiencies is further confused and give rise to the dangerous possibility that only one deficiency will be treated.

However, the neuropsychiatric abnormalities caused by the B12 deficiency will not be corrected and may indeed by worsened.

This formulation presents a problem in the case of a B12 deficient patient, in that the 0.5 mg folate may correct the hematologic abnormalities present, but the 0.5 mg B12 dose may be insufficient to correct a B12 deficiency due to inadequate intrinsic factor.

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