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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 |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00217100 |
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 |
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Kidney Transplantation |
Drug: Folic Acid |
Phase III |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | October 2004 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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. |
Principal Investigator: | Fernando G. Cosio, M.D. | Mayo Clinic |
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 |
Folic Acid |
Vitamin B Complex Hematinics Therapeutic Uses Growth Substances Vitamins |
Hematologic Agents Physiological Effects of Drugs Micronutrients Pharmacologic Actions |