Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis
Completed
Georgetown University
N/A
1999-06-01
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)
Phase 3
1996-09-01
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
attack.
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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
