Overview

This trial is active, not recruiting.

Condition renal transplant recipients
Treatments favorit "high dose" multivitamin, favorit "low dose" multivitamin
Phase phase 2/phase 3
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator Office of Dietary Supplements (ODS)
Start date May 2002
End date October 2011
Trial size 4110 participants
Trial identifier NCT00064753, FAVORIT dk61700 IND

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
favorit "high dose" multivitamin
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
(Placebo Comparator)
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
favorit "low dose" multivitamin
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

Primary Outcomes

Measure
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
time frame: Through July 31, 2011 (censored 3-months post graft failure)

Secondary Outcomes

Measure
Renal graft failure
time frame: Through July 31, 2011
Mortality (All-cause)
time frame: Through July 31, 2011
Individual components of the composite primary endpoint
time frame: Through July 31, 2011
Number of endpoint events that occur
time frame: Through July 31, 2011
Relevant combinations of the components of the composite primary endpoint
time frame: Through July 31, 2011
Creatinine-based estimates of renal function
time frame: Through July 31, 2011

Eligibility Criteria

Male or female participants from 35 years up to 75 years old.

- Age 35 to 75 - chronic renal transplant recipient (graft functioning for at least 6 months) - Cockcroft-Gault serum creatinine based estimate of glomerular filtration rate equal to or greater than 30 ml/min - non-fasting plasma homocysteine in men of 12 or greater micromole/liter, in women greater than or equal to 11 micromole per liter

Additional Information

Official title Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
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
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).