ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis

This study is currently recruiting participants.
Verified by FDA Office of Orphan Products Development, August 1999

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

Investigators
Study Chair:     Christopher S. Wilcox     Georgetown University    
  More Information


Study ID Numbers:   199/14276, GUMC-FDR001544
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 November 30, 2008




Links to all studies - primarily for crawlers