BVAIT: B-Vitamin Atherosclerosis Intervention Trial
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).
Drug: folic acid
Drug: vitamin B12
Drug: vitamin B6
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||B-Vitamin Atherosclerosis Intervention Trial (BVAIT)|
- rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
- change in coronary and abdominal aortic calcification
- neurocognitive change
|Study Start Date:||November 2000|
|Study Completion Date:||February 2007|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114400
|United States, California|
|Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Howard N. Hodis, MD||University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine|