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Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

2014-08-27 03:55:06 | BioPortfolio

Summary

The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.

Description

The hypothesis of the trial is as follows: Treatment with a high dose combination of folic acid, vitamin B6, and vitamin B12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascular disease events) relative to treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement amounts of vitamin B6, vitamin B12, among chronic, stable renal transplant recipients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Renal Transplant Recipients

Intervention

FAVORIT "high dose" multivitamin, FAVORIT "low dose" multivitamin

Location

University of Alabama at Birmingham School of Medicine
Birmingham
Alabama
United States
35233

Status

Active, not recruiting

Source

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:06-0400

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