VEAPS: Vitamin E Atherosclerosis Prevention Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 353
- 试验地点
- 2
- 主要终点
- Rate of change of the 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 E (DL-alpha-tocopherol) supplementation will reduce the progression of early atherosclerosis in healthy individuals over 40 years of age with low-density lipoprotein (LDL) cholesterol levels greater than or equal to 130mg/dL.
详细描述
The primary hypothesis to be tested is that vitamin E supplementation of 400 IU/day exerts positive arterial wall effects by reducing progression of early atherosclerosis in healthy individuals 40 years old or older without clinical evidence of cardiovascular disease (CVD). Ultrasonography will be used to measure the rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT). The beneficial effects of vitamin E supplementation are expected to occur with or without a change in LDL-C levels.
A total of 353 men and women will be recruited for the three-year trial. Participants will be randomized into a treatment group to receive either vitamin E (DL-alpha-tocopherol) 400 IU/day or a placebo. The ultrasound measurement of CCA IMT will be repeated every six months for two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •40 years or older
- •Fasting LDL-C level 130 mg/dL or greater, TG (triglyceride) levels 500mg/dL or lower
排除标准
- •Any clinical signs or symptoms of cardiovascular disease (CVD)
- •Diabetes mellitus or fasting serum glucose 140mg/dL or greater
- •Regular vitamin E supplementation for more than 1 year
- •Lipid standardized plasma vitamin E levels greater than 35 micromoles per liter (μmol/L)
- •Uncontrolled hypertension (diastolic blood pressure 100 mmHg or greater)
- •Thyroid disease (untreated)
- •Renal insufficiency (serum creatinine greater than 2.5 mg/dL)
- •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 abuse, cocaine use)
结局指标
主要结局
Rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT)
次要结局
未报告次要终点