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

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: August 1999

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 Intervention
End Stage Renal Disease
Drug: cyanocobalamin
Drug: folic acid
Drug: pyridoxine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 84
Study Start Date: June 1999
Estimated Study Completion Date: September 2000
Detailed Description:

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


Ages Eligible for Study:   21 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


--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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004495

United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Study Chair: Christopher S. Wilcox Georgetown University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004495     History of Changes
Other Study ID Numbers: 199/14276, GUMC-FDR001544
Study First Received: October 18, 1999
Last Updated: March 24, 2015
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
cardiovascular and respiratory diseases
end stage renal disease
rare disease
renal and genitourinary disorders

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Amino Acid Metabolism, Inborn Errors
Deficiency Diseases
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Metabolism, Inborn Errors
Nutrition Disorders
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Vitamin B Deficiency
Folic Acid
Vitamin B Complex
Growth Substances
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2015