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

This study is currently recruiting patients.

Sponsored by: FDA Office of Orphan Products Development
Georgetown University
Information provided by: FDA Office of Orphan Products Development

Purpose

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.

Condition Treatment or Intervention
End Stage Renal Disease
Hyperhomocysteinemia
 Drug: cyanocobalamin
 Drug: folic acid
 Drug: pyridoxine

MedlinePlus related topics:  Genetic Disorders;   Kidney Failure;   Metabolic Disorders

Study Type: Interventional
Study Design: Treatment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  84

Study start: June 1999

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.

Eligibility

Ages Eligible for Study:  21 Years   -   89 Years,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--Patient Characteristics--


Location and Contact Information


District of Columbia
      Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States; Recruiting
Christopher S. Wilcox  202-687-8539 

Study chairs or principal investigators

Christopher S. Wilcox,  Study Chair,  Georgetown University   

More Information

Study ID Numbers:  199/14276; GUMC-FDR001544
Record last reviewed:  August 1999
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004495
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09
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