The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 835
- 试验地点
- 2
- 主要终点
- Change in mean carotid intima-media thickness
研究概览
简要总结
The purpose of this study is to determine if folic acid supplementation can slow down atherosclerotic progression, age-related cognitive decline and age-related hearing loss.
详细描述
Low levels of B vitamins, in particular folate, and high levels of plasma total homocysteine, have been associated with a variety of age-related diseases and disorders, including cardiovascular disease, dementia and hearing impairment. Extra folate, for example in the form of folic acid, is known to decrease the concentrations of plasma total homocysteine.
We examined whether 0.8 mg/d folic acid could slow down atherosclerotic progression and the above mentioned age-related processes.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50-70 years
- •Men and post-menopausal women
- •Women with a surgically removed uterus were required to be >=55 years
排除标准
- •Plasma total homocysteine <13 or >26 umol/L
- •Serum vitamin B12 <200 pmol/L
- •Self-reported current use of drugs which affect folate metabolism
- •Self-reported current use of drugs believed to influence intima-media thickening, i.e., lipid-lowering drugs, hormone replacement therapy
- •Self-reported medical diagnosis of renal, intestinal, thyroid disease
- •Self-reported medical diagnosis of current cancer
- •Self-reported current use of supplements containing B vitamins
- •Self-reported inability or unwillingness to fast for 12 hours
- •<80% compliance using placebo pills during a 6-week run-in period
- •Not giving written informed consent
- •Participation in other research studies
结局指标
主要结局
Change in mean carotid intima-media thickness
Change in maximum carotid intima-media thickness
次要结局
- Change in carotid distension
- Change in hearing levels (pure tone air conduction averages of 0.5, 1, and 2 kHz & 4, 6 and 8 kHz)
- Cognitive performance at year 3 (cognitive domains: simple speed, cognitive flexibility, and memory; and information processing speed and semantic memory)
- Inflammatory markers and hemostasis markers