Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) (FAVORIT)

This study has been completed.
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00064753
First received: July 11, 2003
Last updated: October 26, 2015
Last verified: October 2015
  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
Chronic Kidney Disease
Cardiovascular Disease
Death
Drug: High Dose Multivitamin
Device: 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 ]
    censored at 3 months after return to dialysis

  • Fatal/Non-fatal MI [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
    censored at 3 months after return to dialysis

  • Fatal/Non-fatal Stroke [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
    censored at 3 months after return to dialysis

  • RSD [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
    censored at 3 months after return to dialysis

  • CVD Death [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
    censored at 3 months after return to dialysis

  • Coronary Artery Revascularization [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
    censored at 3 months after return to dialysis

  • Lower Extremity PAD [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
    censored at 3 months after return to dialysis

  • Carotid Endarterectomy or Angioplasty [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
    censored at 3 months after return to dialysis

  • Abdominal Aortic Aneurysm Repair [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
    censored at 3 months after return to dialysis

  • Renal Artery Revascularization [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
    censored at 3 months after return to dialysis


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

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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 35 - 75 years old
  • Had kidney transplant at least 6 months
  • Calculated Creatinine Clearance must be 25mL/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
    • CHF (end stage)
    • Liver disease (end stage)
    • Severe pulmonary disease
    • Progressive HIV
    • Any other chronic wasting illness
  • If patient had MI, stroke, lower extremity amputation above ankle or percutaneous revascularization procedure (coronary, cerebrovascular, lower extremity) in past 2months
  • If patient had CABG or AAA in past 5 months
  • If patient has conditions that prevent reliable study participation e.g., depression, alcohol or drug abuse, other CVD studies
  • If patient has had multi-organ transplant, except kidney/pancreas
  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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Dietary Supplements (ODS)
Investigators
Study Director: Andrew Levey, M.D. Tufts Medical Center
Principal Investigator: Myra A Carpenter, PhD University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications:

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00064753     History of Changes
Other Study ID Numbers: FAVORIT dk61700 IND 
Study First Received: July 11, 2003
Results First Received: October 26, 2015
Last Updated: October 26, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Brazil: National Health Surveillance Agency

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:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamins
Folic Acid
Vitamin B 12
Hydroxocobalamin
Vitamin B 6
Pyridoxal
Pyridoxine
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics

ClinicalTrials.gov processed this record on July 24, 2016