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Multivitamin Comparison in Kidney Transplant Recipients
This study is currently recruiting participants.
Verified by Mayo Clinic, September 2005
Sponsors and Collaborators: Mayo Clinic
National Institutes of Health (NIH)
University of Wisconsin, Madison
University of California, San Francisco
University of Alabama at Birmingham
Ohio State University
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00217100
  Purpose

This study is being done to compare arteriosclerotic cardiovascular disease in kidney transplant recipient taking a standard multivitamin versus those taking a multivitamin augmented by a high dose combination of folic acid, vitamin B12, and vitamin B6.


Condition Intervention Phase
Kidney Transplantation
Drug: Folic Acid
Phase III

MedlinePlus related topics: Kidney Transplantation
Drug Information available for: Folic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Folic Acid for Vascular Outcome Reduction in Transplantation

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Recurrent or de novo arteriosclerotic disease (CVD), defined as the occurrence of non-fatal arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascularr disease events.

Secondary Outcome Measures:
  • death
  • Myocardial infarction
  • stroke
  • resuscitated sudden death

Estimated Enrollment: 200
Study Start Date: October 2004
Detailed Description:

This is a multicenter, randomized, double-blind controlled clinical trial. The trial has been designed to determine whether total homocysteine lowering treatment with a standard multivitamin augmented by a multivitamin containing no folic acid B12, and vitamin B6, versus treatment with an identical multivitamin containing no folic acid, will reduce the pooled rate of recurrent or new cardiovascular disease outcomes or events. Participants will have a brief visit, at which the participant will have physical measurements, blood pressure and history taken. Urine and blood tests will be performed to determine the levels of homocysteine, vitamins and creatinine. Qualifying participants will be randomly assigned to receive multivitamins containing a high dose of folic acid, vitamin B6, and vitamin B12, or an identical multivitamin containing no folic acid, and estimated average requirement amounts of vitamin B6 and vitamin B12. The participant will be required to return annually throughout the next five years for physical exams, blood and urine tests.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Participants with elevated homocysteine levels that are between the ages of 35-75 years old and have had a kidney transplant with stable renal graft function.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217100

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Brenda M Ingalls-Hanson     507-538-2918     ingallshanson.brenda@mayo.edu    
Principal Investigator: Fernando G Cosio, M.D.            
Sponsors and Collaborators
Mayo Clinic
University of Wisconsin, Madison
University of California, San Francisco
University of Alabama at Birmingham
Ohio State University
Investigators
Principal Investigator: Fernando G. Cosio, M.D. Mayo Clinic
  More Information

Study ID Numbers: 1965-04
Study First Received: September 20, 2005
Last Updated: September 20, 2005
ClinicalTrials.gov Identifier: NCT00217100  
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration

Study placed in the following topic categories:
Folic Acid

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 14, 2009