Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis
End Stage Renal Disease, Hyperhomocysteinemia
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring cardiovascular and respiratory diseases, end stage renal disease, hyperhomocysteinemia, rare disease, renal and genitourinary disorders
Eligibility Criteria
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
Sites / Locations
- Georgetown University Medical Center