CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,110 enrolled
Drug / intervention
High Dose Multivitamin +1 moredrug
Likely dose
High-dose multivitamin: folic acid 5.0 mg daily (plus B6 50 mg, B12 1.0 mg, and other B vitamins); Low-dose multivitamin: folic acid 0.0 mg daily (plus B6 1.4 mg, B12 2.0 mcg, and other B vitamins)AI-extracted
Key inclusion· 4
  • ✓Age 35 to 75 years
  • ✓Kidney transplant recipients at least 6 months post-transplant
  • ✓Calculated creatinine clearance ≥25 mL/min
  • ✓Willing to stop B6, B12, and folic acid supplements for 4-6 weeks prior to baseline visit
Key exclusion· 7
  • ✕Pregnant or lactating
  • ✕Women of childbearing potential not on reliable birth control
  • ✕Conditions that limit life expectancy to <2 years: cancer, end-stage CHF, end-stage liver disease, severe pulmonary disease, progressive HIV, or other chronic wasting illness
  • ✕MI, stroke, lower extremity amputation above ankle, or revascularization procedure (coronary, cerebrovascular, lower extremity) within past 2 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00064753
NCT00064753Phase 3Completed
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Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Jul 15, 2003·Updated Oct 18, 2017

In Brief

A Phase 3 clinical trial evaluating High Dose Multivitamin and Low Dose Multivitamin for Chronic Kidney Disease and 2 related conditions. Completed, enrolled 4,110 participants across 30 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Cardiovascular Disease, Death
CountriesBrazil, Canada, United States
CollaboratorsOffice of Dietary Supplements (ODS)

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 15, 2003
Enrollment StartMay 1, 2002
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 23.0 years ago

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