MedDataX Logo

Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

NCT ID: NCT00064753

Last Updated: 2017-10-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

4110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease Cardiovascular Disease Death

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

homocysteine multi-vitamin cardiovascular disease renal transplant recipients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High Dose Multivitamin

Multivitamin with increased folic acid, vitamin B6 and vitamin B12

Group Type EXPERIMENTAL

High Dose Multivitamin

Intervention Type DRUG

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

Low Dose Multivitamin

Multivitamin devoid of folic acid and with estimated average requirement amounts of vitamin B6 and vitamin B12

Group Type ACTIVE_COMPARATOR

Low Dose Multivitamin

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

multivitamin multivitamin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Office of Dietary Supplements (ODS)

NIH

Sponsor Role collaborator

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

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew Levey, M.D.

Role: STUDY_DIRECTOR

Tufts Medical Center

Myra A Carpenter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, United States

Site Status

Banner Good Samaritan Transplant

Phoenix, Arizona, United States

Site Status

Cedars-Sinai Health System/Center for Kidney Diseases and Transplantation

Los Angeles, California, United States

Site Status

University of California at Los Angeles

Los Angeles, California, United States

Site Status

University of California at San Francisco

San Francisco, California, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Southern Illinois University

Springfield, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Faireview University Medical Center

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Albany Medical Center

Albany, New York, United States

Site Status

State University of New York Downstate Medical Center

Brooklyn, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

The Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Drexel University

Philadelphia, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

University of Wisconsin at Madison

Madison, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Universidade Federal de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

London Health Sciences Center

London, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Brazil Canada

References

Explore related publications, articles, or registry entries linked to this study.

Weiner DE, Carpenter MA, Levey AS, Ivanova A, Cole EH, Hunsicker L, Kasiske BL, Kim SJ, Kusek JW, Bostom AG. Kidney function and risk of cardiovascular disease and mortality in kidney transplant recipients: the FAVORIT trial. Am J Transplant. 2012 Sep;12(9):2437-45. doi: 10.1111/j.1600-6143.2012.04101.x. Epub 2012 May 17.

Reference Type BACKGROUND
PMID: 22594581 (View on PubMed)

Troen AM, Scott TM, D'Anci KE, Moorthy D, Dobson B, Rogers G, Weiner DE, Levey AS, Dallal GE, Jacques PF, Selhub J, Rosenberg IH; FACT Study Investigators. Cognitive dysfunction and depression in adult kidney transplant recipients: baseline findings from the FAVORIT Ancillary Cognitive Trial (FACT). J Ren Nutr. 2012 Mar;22(2):268-276.e3. doi: 10.1053/j.jrn.2011.07.009. Epub 2011 Dec 6.

Reference Type BACKGROUND
PMID: 22153382 (View on PubMed)

Carpenter MA, Weir MR, Adey DB, House AA, Bostom AG, Kusek JW. Inadequacy of cardiovascular risk factor management in chronic kidney transplantation - evidence from the FAVORIT study. Clin Transplant. 2012 Jul-Aug;26(4):E438-46. doi: 10.1111/j.1399-0012.2012.01676.x. Epub 2012 Jul 9.

Reference Type BACKGROUND
PMID: 22775763 (View on PubMed)

Bostom AG, Carpenter MA, Kusek JW, Hunsicker LG, Pfeffer MA, Levey AS, Jacques PF, McKenney J; FAVORIT Investigators. Rationale and design of the Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) trial. Am Heart J. 2006 Sep;152(3):448.e1-7. doi: 10.1016/j.ahj.2006.03.004.

Reference Type BACKGROUND
PMID: 16923411 (View on PubMed)

Weir MR, Gravens-Muller L, Costa N, Ivanova A, Manitpisitkul W, Bostom AG, Diamantidis CJ; FAVORIT Study Investigators. Safety events in kidney transplant recipients: results from the folic Acid for vascular outcome reduction in transplant trial. Transplantation. 2015 May;99(5):1003-8. doi: 10.1097/TP.0000000000000454.

Reference Type BACKGROUND
PMID: 25393158 (View on PubMed)

Carpenter MA, John A, Weir MR, Smith SR, Hunsicker L, Kasiske BL, Kusek JW, Bostom A, Ivanova A, Levey AS, Solomon S, Pesavento T, Weiner DE. BP, cardiovascular disease, and death in the Folic Acid for Vascular Outcome Reduction in Transplantation trial. J Am Soc Nephrol. 2014 Jul;25(7):1554-62. doi: 10.1681/ASN.2013040435. Epub 2014 Mar 13.

Reference Type BACKGROUND
PMID: 24627349 (View on PubMed)

Bostom AG, Carpenter MA, Hunsicker L, Jacques PF, Kusek JW, Levey AS, McKenney JL, Mercier RY, Pfeffer MA, Selhub J; FAVORIT Study Investigators. Baseline characteristics of participants in the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial. Am J Kidney Dis. 2009 Jan;53(1):121-8. doi: 10.1053/j.ajkd.2008.08.010. Epub 2008 Nov 20.

Reference Type RESULT
PMID: 19022547 (View on PubMed)

Bostom AG, Carpenter MA, Kusek JW, Levey AS, Hunsicker L, Pfeffer MA, Selhub J, Jacques PF, Cole E, Gravens-Mueller L, House AA, Kew C, McKenney JL, Pacheco-Silva A, Pesavento T, Pirsch J, Smith S, Solomon S, Weir M. Homocysteine-lowering and cardiovascular disease outcomes in kidney transplant recipients: primary results from the Folic Acid for Vascular Outcome Reduction in Transplantation trial. Circulation. 2011 Apr 26;123(16):1763-70. doi: 10.1161/CIRCULATIONAHA.110.000588. Epub 2011 Apr 11.

Reference Type RESULT
PMID: 21482964 (View on PubMed)

Kang AW, Garber CE, Eaton CB, Risica PM, Bostom AG. Physical Activity and Cardiovascular Risk among Kidney Transplant Patients. Med Sci Sports Exerc. 2019 Jun;51(6):1154-1161. doi: 10.1249/MSS.0000000000001886.

Reference Type DERIVED
PMID: 30629045 (View on PubMed)

Weinrauch LA, Claggett B, Liu J, Finn PV, Weir MR, Weiner DE, D'Elia JA. Smoking and outcomes in kidney transplant recipients: a post hoc survival analysis of the FAVORIT trial. Int J Nephrol Renovasc Dis. 2018 Apr 27;11:155-164. doi: 10.2147/IJNRD.S161001. eCollection 2018.

Reference Type DERIVED
PMID: 29760559 (View on PubMed)

Weinrauch LA, D'Elia JA, Weir MR, Bunnapradist S, Finn PV, Liu J, Claggett B, Monaco AP. Infection and Malignancy Outweigh Cardiovascular Mortality in Kidney Transplant Recipients: Post Hoc Analysis of the FAVORIT Trial. Am J Med. 2018 Feb;131(2):165-172. doi: 10.1016/j.amjmed.2017.08.038. Epub 2017 Sep 21.

Reference Type DERIVED
PMID: 28943384 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U01DK061700

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FAVORIT dk61700 IND

Identifier Type: -

Identifier Source: org_study_id