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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00064753
Recruitment Status : Completed
First Posted : July 15, 2003
Results First Posted : November 26, 2015
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Cardiovascular Disease Death Drug: High Dose Multivitamin Device: Low Dose Multivitamin Phase 2 Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
Study Start Date : May 2002
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 estimated average requirement 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


Outcome Measures
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Primary Outcome Measures :
  1. 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: Up to 6 years (mean 4 years) ]

Secondary Outcome Measures :
  1. Renal Graft Failure [ Time Frame: Up to 6 years (mean 4 years) ]
  2. Mortality (All-cause) [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis

  3. Fatal/Non-fatal Myocardial Infarction (MI) [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis

  4. Fatal/Non-fatal Stroke [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis

  5. Resuscitated Sudden Death (RSD) [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis

  6. CVD Death [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis

  7. Coronary Artery Revascularization [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis

  8. Lower Extremity Peripheral Arterial Disease (PAD) [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis

  9. Carotid Endarterectomy or Angioplasty [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis

  10. Abdominal Aortic Aneurysm Repair [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis

  11. Renal Artery Revascularization [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 35 - 75 years old
  • Had kidney transplant at least 6 months
  • Calculated Creatinine Clearance must be 25 mL/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
    • Congestive heart failure (CHF) (end stage)
    • Liver disease (end stage)
    • Severe pulmonary disease
    • Progressive HIV
    • Any other chronic wasting illness
  • If patient had myocardial infarction (MI), stroke, lower extremity amputation above ankle or percutaneous revascularization procedure (coronary, cerebrovascular, lower extremity) in past 2months
  • If patient had coronary artery bypass graft (CABG) or abdominal aortic aneurysm (AAA) in past 5 months
  • If patient has conditions that prevent reliable study participation e.g., depression, alcohol or drug abuse, other cardiovascular disease (CVD) studies
  • If patient has had multi-organ transplant, except kidney/pancreas
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064753


Locations
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Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Dietary Supplements (ODS)
Investigators
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Study Director: Andrew Levey, M.D. Tufts Medical Center
Principal Investigator: Myra A Carpenter, PhD University of North Carolina, Chapel Hill
More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00064753    
Other Study ID Numbers: FAVORIT dk61700 IND
U01DK061700 ( U.S. NIH Grant/Contract )
First Posted: July 15, 2003    Key Record Dates
Results First Posted: November 26, 2015
Last Update Posted: October 18, 2017
Last Verified: October 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient data and samples are available at the NIDDK Central repository
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: December 2013
URL: https://www.niddkrepository.org/studies/favorit/?query=favorit

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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:
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Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency