Effects of Low-dose B-vitamins Supplementation on Plasma Homocysteine and Framingham Risk Score: Double Blind Randomized Controlled Trial in Healthy Chinese Elderly
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score
研究概览
简要总结
The purpose of this study is to evaluate whether low dose complex B-vitamins (folic acid,vitamin B6 and vitamin B12) can lower the risk of developing hyperhomocysteinemia in an apparently healthy population with low folate/B12 and high Hcy status.
详细描述
Hyperhomocysteinemia has been well known as an independent risk factor for CVD. Numerous studies have demonstrated that certain kinds of vitamin B(folic acid,vitamin B6 and vitamin B12)can reduce Hcy level and may prevent CVD. However, the majority of those studies has been conducted always used high dose vitamin in patient or high risk population. There is thus absence of data that the effectiveness of low dose complex B-vitamins on the apparently Chinese elderly population with relative sub-nutritional status. Our study is just focus on the aforementioned aspect.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female residents living in the field site for at least 12 months
- •Aged 60-74 years
排除标准
- •History of chronic disease and taking medications for treatment such as CVD, COPD, cancer, severe renal and liver disease, diabetes.
- •Use of multivitamins, and individual vitamins such as folic acid, B12, or B6 in the last 6 months.
- •Taking medications known to interfere with folate metabolism, including methotrexate, tamoxifen, L-DOPA, niacin, phenytoin, bile acid sequestrants; anticonvulsant medications (such as dilantin, phenytoin, and primidone), Metformin, Sulfasalazine.
- •Conditions that prevent participation or compliance such as Downs syndrome, mental problems, or severe cognitive impairment
结局指标
主要结局
plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score
时间窗: 6,12 and 18 months
次要结局
- systolic blood pressure, diastolic blood pressure and hemoglobin(6 and 12 months)
研究者
Liu Jianmeng
Institute of reproductive and Child Health
Peking University