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Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients with End Stage Renal Disease Receiving Hemodialysis
This study is currently recruiting patients.
Sponsored by: | FDA Office of Orphan Products Development Georgetown University
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Information provided by: | FDA Office of Orphan Products Development |
Purpose
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.
Condition | Treatment or Intervention |
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End Stage Renal Disease Hyperhomocysteinemia |
Drug: cyanocobalamin Drug: folic acid Drug: pyridoxine |
MedlinePlus related topics: Genetic Disorders; Kidney Failure; Metabolic Disorders
Study Type: Interventional
Study Design: Treatment, Efficacy Study
Expected Total Enrollment: 84
Study start: June 1999
PROTOCOL OUTLINE: This is a randomized, placebo controlled study. Patients are stratified according to prestudy homocysteine levels (above or below average). Patients are randomized to receive placebo or one of two doses of oral folic acid, with or without pyridoxine and cyanocobalamin. Arm I: Patients receive oral placebo daily. Arm II: Patients receive oral pyridoxine, cyanocobalamin, and oral placebo daily. Arm III: Patients receive oral pyridoxine, cyanocobalamin, and folic acid daily. Arm IV: Patients receive oral pyridoxine and cyanocobalamin plus a higher dose of folic acid daily. Arm V: Patients receive oral placebo and oral folic acid daily. Arm VI: Patients receive oral placebo and higher dose folic acid daily. Treatment continues for 8 weeks.
Eligibility
Ages Eligible for Study: 21 Years - 89 Years, Genders Eligible for Study: Both
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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