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

Primary Purpose

End Stage Renal Disease, Hyperhomocysteinemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cyanocobalamin
folic acid
pyridoxine
Sponsored by
Georgetown University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring cardiovascular and respiratory diseases, end stage renal disease, hyperhomocysteinemia, rare disease, renal and genitourinary disorders

Eligibility Criteria

21 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 18, 1999
Last Updated
March 24, 2015
Sponsor
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT00004495
Brief Title
Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
August 1999
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Georgetown University

4. Oversight

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hyperhomocysteinemia
Keywords
cardiovascular and respiratory diseases, end stage renal disease, hyperhomocysteinemia, rare disease, renal and genitourinary disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyanocobalamin
Intervention Type
Drug
Intervention Name(s)
folic acid
Intervention Type
Drug
Intervention Name(s)
pyridoxine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher S. Wilcox
Organizational Affiliation
Georgetown University
Official's Role
Study Chair
Facility Information:
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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