BVAIT: B-Vitamin Atherosclerosis Intervention Trial

Sponsor

National Institute on Aging (NIA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00114400

Collaborator

Leiner Health Products (Industry)

506

Enrollment

Location

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Atherosclerosis	Drug: folic acid Drug: vitamin B12 Drug: vitamin B6	Phase 2/Phase 3

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).

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

B-Vitamin Atherosclerosis Intervention Trial (BVAIT)

Study Start Date :

Nov 1, 2000

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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