NCT01095211已完成不适用
Effect of B-Vitamins on Cognitive Function in Elderly People
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Cognitive function
研究概览
简要总结
Observation studies documented a correlation between plasma concentrations of homocysteine and cognitive decline with age. The study hypothesis was that high doses of B-vitamins (as effective homocysteine lowering treatment) can improve cognitive function in elderly people.
详细描述
We performed a treatment with therapeutic doses of B-vitamins (folic acid, cobalamin, vitamin B6) for 45 days. We collected blood and tested the concentrations of the metabolic markers in blood at start, 3 weeks later and at the end. Cognitive function was tested at start and at the end.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 65 years and glomerular filtration rate (GFR) > 35 ml/min
排除标准
- •acute cancer or those who had coronary or cerebral event or thrombosis in the last 3 months were not eligible for the study.
- •furthermore, people who had dementia (mini-mental state-examination scores MMSE < 15)
- •those treated with B-vitamins
- •those with renal insufficiency
- •those receiving drugs that affect Hcy-metabolism (methotrexate, anti-epileptics, L-dopa) were not allowed to participate
研究组 & 干预措施
B-Vitamins
Active Comparator
folic acid, cobalamin, vitamin B6
干预措施: B-vitamin complex (Drug)
placebo
Placebo Comparator
none of the vitamins (99.5% mannitol)
干预措施: B-vitamin complex (Drug)
结局指标
主要结局
Cognitive function
时间窗: baseline and 45 days later
次要结局
未报告次要终点
研究者
研究点 (1)
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