End Stage Renal Disease Clinical Trial
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | September 2000 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 89 Years |
Eligibility |
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of end stage renal disease requiring regular hemodialysis treatment 3 times weekly - Baseline predialysis total homocysteine concentration in plasma greater than 16 micromoles/L - No prior or concurrent pernicious anemia - No blood smear examination showing unexplained macrocytosis --Prior/Concurrent Therapy-- - Chemotherapy: No concurrent chemotherapy for cancer - Other: No concurrent levodopa or carbidopa No concurrent penicillamine or trimethoprim-sulfonamide combination No concurrent antiviral therapy No concurrent anticonvulsants --Patient Characteristics-- - Hematopoietic: Hematocrit at least 25% - Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No Parkinson's disease No convulsions or epilepsy requiring treatment No lactose intolerance or allergy to milk products No history of allergic sensitization following administration of folic acid, pyridoxine (vitamin B6), or cyanocobalamin (vitamin B12) No vitamin B12 concentration below lower limit of normal (150 picamole/L) No untreated hypothyroidism or psoriasis |
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Georgetown University Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Georgetown University |
United States,
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