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

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	Georgetown University
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004495

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: argininosuccinic aciduria carbamoyl phosphate synthetase I deficiency citrullinemia N-acetylglutamate synthase deficiency ornithine translocase deficiency

MedlinePlus related topics: B Vitamins Dialysis Kidney Failure

Drug Information available for: Pyridoxine hydrochloride Folic acid Pyridoxine Vitamin B 12 Hydroxocobalamin Vitamin B 6

U.S. FDA Resources

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004495

Locations

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

FDA Office of Orphan Products Development

Georgetown University

Investigators

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:	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
hyperhomocysteinemia
rare disease
renal and genitourinary disorders

Additional relevant MeSH terms:

Kidney Diseases
Kidney Failure, Chronic
Hyperhomocysteinemia
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition

Nutrition Disorders
Folic Acid
Hydroxocobalamin
Vitamin B 12
Pyridoxine
Vitamin B 6
Pyridoxal
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on February 12, 2012