NCT00114400

BVAIT: B-Vitamin Atherosclerosis Intervention Trial

B-Vitamin Atherosclerosis Intervention Trial (BVAIT)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 506 (planned)
• Sponsor: National Institute on Aging (NIA) · NIH
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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).

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).

Conditions

• Atherosclerosis

Interventions

Type	Name	Description
DRUG	folic acid
DRUG	vitamin B12
DRUG	vitamin B6

Timeline

• Start date: 2000-11-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2005-06-15
• Last updated: 2009-12-11

Locations

1 site across 1 country: United States