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Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00064753
First received: July 11, 2003
Last updated: March 2, 2010
Last verified: March 2010
History of Changes

July 11, 2003
March 2, 2010
May 2002
October 2011   (final data collection date for primary outcome 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) ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00064753 on ClinicalTrials.gov Archive Site
  • Renal graft failure [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
  • Mortality (All-cause) [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
  • Individual components of the composite primary endpoint [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
  • Number of endpoint events that occur [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
  • Relevant combinations of the components of the composite primary endpoint [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
  • Creatinine-based estimates of renal function [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Renal Transplant Recipients
  • Dietary Supplement: 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
  • Dietary Supplement: 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
  • Active Comparator: High Dose
    Multivitamin with increased folic acid, vitamin B6 and vitamin B12
    Intervention: Dietary Supplement: FAVORIT "high dose" multivitamin
  • Placebo Comparator: Low Dose
    Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
    Intervention: Dietary Supplement: FAVORIT "low dose" multivitamin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4110
October 2011
October 2011   (final data collection date for primary outcome measure)
  • 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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Canada
 
NCT00064753
FAVORIT dk61700 IND
Yes
Andrew Bostom, MD, Principal Investigator, Lifespan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Dietary Supplements (ODS)
Study Director: Andrew Bostom, M.D. abostom@lifespan.org
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP