HIGH DOSE FOLIC ACID, VITAMINS B6 & B12 ON ARTERIOSCLEROTIC CARDIOVASC OUTCOMES

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Kidney transplant recipients experience 4 times the number of heart disease outcomes relative to the general population. Risk factors that account for a part of this increased risk are age, sex, cigarette smoking, diabetes, high blood pressure, and high cholesterol levels. Some of these risk factors cannot be changed. Medical management of those risk factors that can be changed may be complicated by possible interactions with immunosuppressant (anti-rejection) medications and other health conditions. Therefore, there is a need to identify other risk factors of heart disease that are easier to safely manage. High homocysteine levels are one such risk factor. Homocysteine is a normal product of protein breakdown in the body. Previous studies have suggested that an excessive amount of homocysteine in the body can result in increased risk for heart disease. Studies also suggest that vitamin supplements of folic acid and vitamins B6 and B12 help to reduce any homocysteine excess in the body. This study hopes to show that by reducing the level of homocysteine in the body, the risk of heart disease is also reduced among kidney transplant patients. Examining and treating high homocysteine levels in the blood of transplant patients can be safely and quickly achieved at low cost with folic acid and B vitamin supplements. This is a five year, multicenter, double-blinded study which will enroll approximately 200 subjects at this site, and approximately 4000 overall. Subjects will take a multivitamin once daily. Patients will be screened prior to participation and randomized (as in the flip of a coin) approximately one month after screening to one of the two vitamin treatment arms: multivitamin with high dose combinations of folic acid, B6, and B12 or multivitamin with no folic acid and regular amounts of vitamin B6 and B12. Patients will undergo yearly laboratory assessments and clinic visits as well as telephone visits six months in between the clinic visits.'