Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)4,110 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

4,110

Conditions

Chronic Kidney Disease Cardiovascular Disease Death

Interventions

High Dose MultivitaminDRUG

Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg

Low Dose MultivitaminDEVICE

Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 35 - 75 years old * Had kidney transplant at least 6 months * Calculated Creatinine Clearance must be 25 mL/min or greater * Must be willing to stop supplements (B6, B12, folic acid) for 4-6 weeks prior to visit Exclusion Criteria: * If pregnant or lactating * If of child bearing potential and not on birth control * If any of the following will limit life expectancy to less than 2 yrs: * Cancer * Congestive heart failure (CHF) (end stage) * Liver disease (end stage) * Severe pulmonary disease * Progressive HIV * Any other chronic wasting illness * If patient had myocardial infarction (MI), stroke, lower extremity amputation above ankle or percutaneous revascularization procedure (coronary, cerebrovascular, lower extremity) in past 2months * If patient had coronary artery bypass graft (CABG) or abdominal aortic aneurysm (AAA) in past 5 months * If patient has conditions that prevent reliable study participation e.g., depression, alcohol or drug abuse, other cardiovascular disease (CVD) studies * If patient has had multi-organ transplant, except kidney/pancreas

Locations (30)

Outcomes

Primary Outcomes

Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events