Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis
Sponsored by FDA Office of Orphan Products Development
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.
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
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
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
Study Locations And Contact Information
Georgetown University Medical Center, Washington District of Columbia
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