Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
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
  Purpose

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.


Condition Intervention Phase
Renal Transplant Recipients
Dietary Supplement: FAVORIT "high dose" multivitamin
Dietary Supplement: FAVORIT "low dose" multivitamin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4110
Study Start Date: May 2002
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High Dose
Multivitamin with increased folic acid, vitamin B6 and vitamin B12
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
Placebo Comparator: Low Dose
Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
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

Detailed 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

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064753

  Show 30 Study Locations
Sponsors and Collaborators
Investigators
Study Director: Andrew Bostom, M.D. abostom@lifespan.org
  More Information

Additional Information:
No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew Bostom, MD, Principal Investigator, Lifespan
ClinicalTrials.gov Identifier: NCT00064753     History of Changes
Other Study ID Numbers: FAVORIT dk61700 IND
Study First Received: July 11, 2003
Last Updated: March 2, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Brazil: Agencia Nacional de Vigilancia Sanitaria

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
homocysteine
multi-vitamin
cardiovascular disease
renal transplant recipients

Additional relevant MeSH terms:
Folic Acid
Vitamin B 12
Vitamin B 6
Vitamin B Complex
Vitamins
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014