Overview

Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis

Status:
Completed
Trial end date:
2000-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Georgetown University
Treatments:
Folic Acid
Hydroxocobalamin
Pyridoxine
Vitamin B 12
Vitamin B Complex
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