Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis
cyanocobalamin
+ folic acid
+ pyridoxine
Amino Acid Metabolism, Inborn Errors+25
+ Avitaminosis
+ Chronic Disease
Treatment Study
Summary
Study start date: June 1, 1999
Actual date on which the first participant was enrolled.PROTOCOL OUTLINE: This is a randomized, placebo controlled study. Patients are stratified according to prestudy homocysteine levels (above or below average). Patients are randomized to receive placebo or one of two doses of oral folic acid, with or without pyridoxine and cyanocobalamin. Arm I: Patients receive oral placebo daily. Arm II: Patients receive oral pyridoxine, cyanocobalamin, and oral placebo daily. Arm III: Patients receive oral pyridoxine, cyanocobalamin, and folic acid daily. Arm IV: Patients receive oral pyridoxine and cyanocobalamin plus a higher dose of folic acid daily. Arm V: Patients receive oral placebo and oral folic acid daily. Arm VI: Patients receive oral placebo and higher dose folic acid daily. Treatment continues for 8 weeks. Completion date provided represents the completion date of the grant per OOPD records
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.84 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 21 to 89 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Georgetown University Medical Center
Washington D.C., United StatesOpen Georgetown University Medical Center in Google Maps