Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) - Full Text View

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Office of Dietary Supplements (ODS)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00064753

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	Intervention	Phase
Renal Transplant Recipients	Dietary Supplement: FAVORIT "high dose" multivitamin Dietary Supplement: FAVORIT "low dose" multivitamin	Phase II Phase III

MedlinePlus related topics: Dietary Supplements Kidney Transplantation

Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine Calcium gluconate Homocysteine Riboflavin Thiamine 3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2-hydroxyethyl)-4-m- ethylthiazolium chloride, monohydrochloride Ascorbic acid Niacinamide Biotin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]
Individual components of the composite primary endpoint [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
Number of endpoint events that occur [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
Relevant combinations of the components of the composite primary endpoint [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]
Creatinine-based estimates of renal function [ Time Frame: Through July 31, 2011 ] [ Designated as safety issue: Yes ]

Enrollment:	4110
Study Start Date:	May 2002
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
High Dose: Active Comparator Multivitamin with increased folic acid, vitamin B6 and vitamin B12	Dietary Supplement: FAVORIT "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
Low Dose: Placebo Comparator Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12	Dietary Supplement: FAVORIT "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

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

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064753

Show 30 Study Locations

Sponsors and Collaborators

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

Office of Dietary Supplements (ODS)

Investigators

Study Director:

Andrew Bostom, M.D.

abostom@lifespan.org

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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. Epub 2008 Nov 20.

Responsible Party:	Lifespan ( Andrew Bostom, MD, Principal Investigator )
Study ID Numbers:	FAVORIT dk61700
Study First Received:	July 11, 2003
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00064753
Health Authority:	United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board; Canada: Health Canada; Brazil: Agencia Nacional de Vigilancia Sanitaria

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

homocysteine
multi-vitamin
cardiovascular disease
renal transplant recipients

Study placed in the following topic categories:

Folic Acid
Calcium, Dietary
Niacinamide
Riboflavin
Hydroxocobalamin
Thiamine

Vitamin B 12
Pyridoxine
Biotin
Ascorbic Acid
Vitamin B 6

Additional relevant MeSH terms:

Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins

Hematologic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009