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Vitamin C (Ascorbic Acid) |
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Clinical Trial: Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
This study is currently recruiting patients.
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 | Treatment or Intervention | Phase |
|---|---|---|
| Renal transplant recipients | Drug: multi-vitamin | Phase II Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Further Study Details:
Expected Total Enrollment: 4000
Study start: May 2002; Expected completion: May 2007
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 - 75 Years, Genders Eligible for Study: Both
Criteria
- Age 35 to 75
- chronic renal transplant recipient (graft functioning for at least 6 months)
- Cockcroft-Gault serum creatinine based estimate of glomerular filtration rate equal to or greater than 30 ml/min
- non-fasting plasma homocysteine in men of 12 or greater micromole/liter, in women greater than or equal to 11 micromole per liter
Location and Contact Information
Joyce L McKenney, MA, MPH 401-444-4833 jmckenney@lifespan.org
Alabama
University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, 35233, United States; Recruiting
Patsy Jones, R.N. 205-934-1389 patsyj@uab.edu
California
University of California at San Francisco, San Francisco, California, 94143-0780, United States; Recruiting
Winifred Kryda 415-476-5979 krydaw@ucsf.edu
University of California at Los Angeles, Los Angeles, California, United States; Recruiting
Rebecca Salas 310-794-8522 RSalas@mednet.ucla.edu
Cedars-Sinai Health System/Center for Kidney Diseases and Transplantation, Los Angeles, California, 90048, United States; Recruiting
Ashley Vo, Pharm.D. 310-423-2641 Ashley.Vo@cshs.org
Indiana
Indiana University, Indianapolis, Indiana, 46202, United States; Recruiting
Scott Herring, R.N., CCTC 317-278-0410 SHerring@clarian.org
Iowa
University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States; Recruiting
Rou-Yee Chenhsu 319-384-5792 Rou-Yee-Chenhsu@uiowa.edu
Maryland
University of Maryland Medical Center, Baltimore, Maryland, 21201, United States; Recruiting
Deserea Russell, M.S. 410-328-2010 drussell@medicine.umaryland.edu
Michigan
University of Michigan Medical Center, Ann Arbor, Michigan, 48109-0364, United States; Recruiting
Karen Wisniewski 734-936-4811 karenbo@umich.edu
Minnesota
Hennepin County Medical Center, Minneapolis, Minnesota, 55404, United States; Recruiting
Tracy Anderson-Haag, Pharm.D. 612-347-7797 teresa.anderson-haag@co.hennepin.mn.us
Missouri
Washington University, St. Louis, Missouri, 63110, United States; Recruiting
Janet Riley, R.N., CRC 314-747-2289 rileyja@msnotes.wustl.edu
New York
Albany Medical Center, Albany, New York, 12208, United States; Recruiting
Julie Hasselbarth 518-262-6422 Hasselj@mail.amc.edu
State University of New York Downstate Medical Center, Brooklyn, New York, 11203, United States; Recruiting
Sima Terebelo, RPA-C 718-270-8216 sima.terebelo@downstate.edu
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States; Recruiting
Judy Coffman 919-660-6878 Coffm005@mc.duke.edu
Ohio
The Ohio State University Medical Center, Columbus, Ohio, 43210-1228, United States; Recruiting
Michelle R. Vermillion 614-293-6091 vermillion-1@medctr.osu.edu
Oregon
Oregon Health Sciences University, Portland, Oregon, 97201-2940, United States; Recruiting
Tammy S LaBeck, R.N., B.S.N., CNN 503-494-6893 labeckt@ohsu.edu
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Recruiting
Joyce McKenney 401-444-4833 Jmckenney@lifespan.org
Andrew Bostom, M.D. (401) 444-6460 Abostom@lifespan.org
Andrew Bostom, M.D. (401) 444-6460 Abostom@lifespan.org
Rhode Island Hospital/Lifespan, Providence, Rhode Island, 02903, United States; Recruiting
Maria Medeiros, R.N. 401-444-7525 mmedeiros@lifespan.org
Wisconsin
Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States; Recruiting
Cathy Bromberek, R.N., B.S.N., CCRC 414-456-6943 Cbromber@mcw.edu
University of Wisconsin at Madison, Madison, Wisconsin, 53792-1735, United States; Recruiting
Nancy Radke, M.S.N. 608-262-7159 nancy@tx.surgery.wisc.edu
Canada, Ontario
London Health Sciences Center, London, Ontario, N6A5A5, Canada; Recruiting
Ruth Bullas 519-685-8500 Ext. 34769 ruth.bullas@lhsc.on.ca
Toronto General Hospital, Toronto, Ontario, Canada; Recruiting
Jan Mitchell 416-340-3125 jan.mitchell@uhn.on.ca
Study chairs or principal investigators
Andrew Bostom, M.D., Study Director, abostom@lifespan.org
More Information
http://www.cscc.unc.edu/favorit/
Study ID Numbers: FAVORIT
Record last reviewed: January 2005
Last Updated: January 4, 2005
Record first received: July 11, 2003
ClinicalTrials.gov Identifier: NCT00064753
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: January 2005
Last Updated: January 4, 2005
Record first received: July 11, 2003
ClinicalTrials.gov Identifier: NCT00064753
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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