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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004495
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
End Stage Renal Disease Hyperhomocysteinemia Drug: cyanocobalamin Drug: folic acid Drug: pyridoxine

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


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Primary Purpose: Treatment
Study Start Date : June 1999
Estimated Study Completion Date : September 2000


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004495


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

ClinicalTrials.gov Identifier: NCT00004495     History of Changes
Other Study ID Numbers: 199/14276
GUMC-FDR001544
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: August 1999

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 Complex
Pyridoxine
Vitamin B 12
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs