BVAIT: B-Vitamin Atherosclerosis Intervention Trial - Full Text View

Sponsors and Collaborators:	National Institute on Aging (NIA) Leiner Health Products
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00114400

Purpose

The purpose of this study is to examine whether vitamin B supplementation will reduce the progression of early atherosclerosis in individuals over 40 years old and without clinical evidence of cardiovascular disease (CVD).

Condition	Intervention	Phase
Atherosclerosis	Drug: folic acid Drug: vitamin B12 Drug: vitamin B6	Phase II Phase III

Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	B-Vitamin Atherosclerosis Intervention Trial (BVAIT)

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)

Secondary Outcome Measures:

change in coronary and abdominal aortic calcification
neurocognitive change

Estimated Enrollment:	506
Study Start Date:	November 2000
Estimated Study Completion Date:	February 2007

Detailed Description:

The primary hypothesis to be tested is that daily vitamin B supplementation reduces progression of early atherosclerosis. Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery and CT will be used to measure coronary and aortic calcium. The beneficial effects of vitamin B supplementation are expected to occur with or without a change in LDL-C levels.

A total of 506 men and women will be randomized to receive either 1) vitamin B supplementation consisting of folic acid 5mg, vitamin B12 0.4mg, and vitamin B6 50mg, or 2) a matching placebo. Participants will receive ultrasonography at baseline and every 6 months for 2.5 to 4.5 years, and CT scan at baseline and end of study (2.5 to 4.5 years).

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female (postmenopausal)
40 years or older
Fasting plasma homocysteine 8.5 micromoles per liter (µmol/L) or greater

Exclusion Criteria:

Any clinical signs or symptoms of cardiovascular disease (CVD)
Diabetes mellitus or fasting serum glucose 140 mg/dL or greater
Triglyceride (TG) levels 500mg/dL or greater
Serum creatinine greater than 1.6 mg/dL
Uncontrolled hypertension (systolic blood pressure 160 mmHg or greater and/or diastolic blood pressure 100 mmHg or greater)
Thyroid disease (untreated)
Life threatening disease with prognosis less than 5 years
Alcohol intake greater than 5 drinks per day (1 drink = 1 1/2 oz distilled spirits, 4 oz wine, or 12 oz beer) or substance abuse (intravenous drug use, cocaine use)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114400

Locations

United States, California
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, United States, 90033

Sponsors and Collaborators

National Institute on Aging (NIA)

Leiner Health Products

Investigators

Principal Investigator:

Howard N. Hodis, MD

University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

More Information

Study ID Numbers:	AG0024, R01AG017160
Study First Received:	June 14, 2005
Last Updated:	February 15, 2007
ClinicalTrials.gov Identifier:	NCT00114400
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

cardiovascular disease
CVD

Study placed in the following topic categories:

Folic Acid
Arterial Occlusive Diseases
Atherosclerosis
Hydroxocobalamin
Vascular Diseases

Vitamin B 12
Pyridoxine
Arteriosclerosis
Vitamin B 6

Additional relevant MeSH terms:

Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins

Hematologic Agents
Physiological Effects of Drugs
Cardiovascular Diseases
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009