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

July 11, 2003
October 26, 2015
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 ]
    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
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
  • Chronic Kidney Disease
  • Cardiovascular Disease
  • Death
  • 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
  • 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
  • Experimental: High Dose Multivitamin
    Multivitamin with increased folic acid, vitamin B6 and vitamin B12
    Intervention: Drug: High Dose Multivitamin
  • Active Comparator: Low Dose Multivitamin
    Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12
    Intervention: Device: Low Dose Multivitamin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4110
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
35 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Canada
 
NCT00064753
FAVORIT dk61700 IND
Yes
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Dietary Supplements (ODS)
Study Director: Andrew Levey, M.D. Tufts Medical Center
Principal Investigator: Myra A Carpenter, PhD University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
October 2015

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