Atherosclerosis Clinical Trial
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).
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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