B-Vitamin Atherosclerosis Intervention Trial (BVAIT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 506
- 试验地点
- 2
- 主要终点
- rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female (postmenopausal)
- •40 years or older
- •Fasting plasma homocysteine 8.5 micromoles per liter (µmol/L) or greater
排除标准
- •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)
结局指标
主要结局
rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
次要结局
- change in coronary and abdominal aortic calcification
- neurocognitive change