Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis
OBJECTIVES: I. Compare the efficacy of two doses of folic acid in normalizing plasma total
homocysteine concentration in patients with end stage renal disease receiving regular
hemodialysis therapy resulting in hyperhomocysteinemia.
II. Determine the requirement of co-supplementation with extra pyridoxine (vitamin B6) and
cyanocobalamin (vitamin B12) daily in these patients.
III. Assess the safety and tolerability of this therapy in these patients.
National Institute of Neurological Disorders and Stroke (NINDS)
A stroke occurs when part of the brain is damaged from lack of normal blood supply. This may
result in difficulty with feeling, speech, muscle strength or coordination, movement,
thinking, or other brain functions. Having a stroke increases the risk of another stroke
occurring in the future. Higher blood levels of a natural chemical known as homocysteine may
contribute to hardening of the arteries in the brain or heart and increase the risk of stroke
or heart attack. Folic acid, vitamin B6 (pyridoxine), and vitamin B12 (cyanocobalamin) may
lower blood levels of homocysteine and reduce the risk of having another stroke or a heart
The primary objective of this study is to test the hypothesis that administration of folate,
pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with
advanced chronic renal failure or end stage renal disease and abnormally high plasma
homocysteine levels will lower the homocysteine levels and the death rate compared to
patients who receive placebo. The secondary objective is to test the hypothesis that intake
of the vitamins compared to placebo decreases the incidence of myocardial infarction,
disabling stroke, and amputation of a lower extremity and, in hemodialysis patients,
thrombosis of the vascular access.
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