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

September 17, 2017 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4110

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04023-900
        • Universidade Federal de São Paulo
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Center
      • Toronto, Ontario, Canada, M5G 2N2
        • Toronto General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham School of Medicine
    • Arizona
      • Phoenix, Arizona, United States, 85004-1608
        • Banner Good Samaritan Transplant
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Health System/Center for Kidney Diseases and Transplantation
      • Los Angeles, California, United States, 90095-7306
        • University of California at Los Angeles
      • San Francisco, California, United States, 94143-0780
        • University of California at San Francisco
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Springfield, Illinois, United States, 62794-9638
        • Southern Illinois University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Brigham and Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0364
        • University of Michigan Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55455
        • Faireview University Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Brooklyn, New York, United States, 11203
        • State University of New York Downstate Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, United States, 27834
        • East Carolina University
    • Ohio
      • Columbus, Ohio, United States, 43210-1228
        • The Ohio State University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97201-2940
        • Oregon Health Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102-1192
        • Drexel University
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin At Madison
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • multivitamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Up to 6 years (mean 4 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Graft Failure
Time Frame: Up to 6 years (mean 4 years)
Up to 6 years (mean 4 years)
Mortality (All-cause)
Time Frame: Up to 6 years (mean 4 years)
censored at 3 months after return to dialysis
Up to 6 years (mean 4 years)
Fatal/Non-fatal Myocardial Infarction (MI)
Time Frame: Up to 6 years (mean 4 years)
censored at 3 months after return to dialysis
Up to 6 years (mean 4 years)
Fatal/Non-fatal Stroke
Time Frame: Up to 6 years (mean 4 years)
censored at 3 months after return to dialysis
Up to 6 years (mean 4 years)
Resuscitated Sudden Death (RSD)
Time Frame: Up to 6 years (mean 4 years)
censored at 3 months after return to dialysis
Up to 6 years (mean 4 years)
CVD Death
Time Frame: Up to 6 years (mean 4 years)
censored at 3 months after return to dialysis
Up to 6 years (mean 4 years)
Coronary Artery Revascularization
Time Frame: Up to 6 years (mean 4 years)
censored at 3 months after return to dialysis
Up to 6 years (mean 4 years)
Lower Extremity Peripheral Arterial Disease (PAD)
Time Frame: Up to 6 years (mean 4 years)
censored at 3 months after return to dialysis
Up to 6 years (mean 4 years)
Carotid Endarterectomy or Angioplasty
Time Frame: Up to 6 years (mean 4 years)
censored at 3 months after return to dialysis
Up to 6 years (mean 4 years)
Abdominal Aortic Aneurysm Repair
Time Frame: Up to 6 years (mean 4 years)
censored at 3 months after return to dialysis
Up to 6 years (mean 4 years)
Renal Artery Revascularization
Time Frame: Up to 6 years (mean 4 years)
censored at 3 months after return to dialysis
Up to 6 years (mean 4 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 11, 2003

First Submitted That Met QC Criteria

July 14, 2003

First Posted (Estimate)

July 15, 2003

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

September 17, 2017

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAVORIT dk61700 IND
  • U01DK061700 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient data and samples are available at the NIDDK Central repository

IPD Sharing Time Frame

December 2013

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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