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

Sponsors and Collaborators:	FDA Office of Orphan Products Development 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

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

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Efficacy Study

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

Study ID Numbers:	199/14276, GUMC-FDR001544
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004495
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

Study placed in the following topic categories:

Renal Insufficiency
Metabolic Diseases
Hyperhomocysteinemia
Amino Acid Metabolism, Inborn Errors
Hydroxocobalamin
Respiration Disorders
Kidney Failure, Chronic
Rare Diseases
Vitamin B 12
Vitamin B 6

Folic Acid
Metabolism, Inborn Errors
Inborn amino acid metabolism disorder
Urologic Diseases
Genetic Diseases, Inborn
Renal Insufficiency, Chronic
Pyridoxine
Kidney Diseases
Metabolic disorder
Kidney Failure

Additional relevant MeSH terms:

Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins

Hematologic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009