Official Title: “B-Vitamin Atherosclerosis Intervention Trial (BVAIT)”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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).

Intervention(s) in this Clinical Trial

• Drug: folic acid
• Drug: vitamin B12
• Drug: vitamin B6

Primary Measures

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

Secondary Measures

• change in coronary and abdominal aortic calcification
• neurocognitive change

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Aging (NIA)

Overall Clinical Trial Officials and Contacts

Howard N. Hodis, MD Principal Investigator University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00114400

Study ID Number: AG0024

ClinicalTrials.gov Identifier: NCT00114400

Health Authority: United States: Federal Government