Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 1999 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Georgetown University
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: October 18, 1999
Last updated: June 23, 2005
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
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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00004495

United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Christopher S. Wilcox    202-687-8539      
Sponsors and Collaborators
Georgetown University
Study Chair: Christopher S. Wilcox Georgetown University
  More Information

No publications provided Identifier: NCT00004495     History of Changes
Other Study ID Numbers: 199/14276, GUMC-FDR001544
Study First Received: October 18, 1999
Last Updated: June 23, 2005
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
Vitamins processed this record on February 25, 2015