Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis
NCT00004495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2015-03-25
Summary
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.
Conditions
- End Stage Renal Disease
- Hyperhomocysteinemia
Interventions
- DRUG
-
cyanocobalamin
- DRUG
-
folic acid
- DRUG
-
pyridoxine
Sponsors & Collaborators
-
Georgetown University
lead OTHER
Principal Investigators
-
Christopher S. Wilcox · Georgetown University
Study Design
- Purpose
- TREATMENT
Eligibility
- Min Age
- 21 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-06-30
- Completion
- 2000-09-30
Countries
- United States
Study Locations
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