Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- depression rating scale
研究概览
简要总结
Background: Vitamin B12 and folate are essential to brain health. Sub optimal status of vitamin B12 and folate leads to elevation of plasma homocysteine concentration, which is associated with Dementia. Vitamin B12 and folate supplementation improved the cognitive function of demented subjects with hyperhomocysteinaemia in a pilot study.
Objective: To determine the effectiveness of vitamin B12 and folate supplementation in preserving cognitive function of subjects with early dementia
详细描述
After stratified randomization by mini mental state examination scores, supplement group subjects take 1 mg of methylcobalamin and 5 mg of folic acid daily, while placebo group subjects take placebo capsules. The primary outcome is Mattis dementia rating scale. The secondary outcomes are mini mental state examination, neuropsychiatric inventory, and Cornell scale for depression in dementia. These measurements will be performed at baseline and every six months for 24 months. Fasting plasma homocysteine concentrations are measured at baseline and 18-month follow-up.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dementia of Alzheimer's or vascular type
- •Early dementia defined by Clinical Dementia Rating of 1.
排除标准
- •lives alone
- •significant communication problems
- •significant co-existing diseases
- •blood tests:vitamin B12< 150 pmol/l, serum creatinine> 250 mol/l, hypothyroidism and syphilis
结局指标
主要结局
depression rating scale
时间窗: at 6 months, 12 months and 18 months
dementia rating scale
时间窗: at 6 months, 12 months and 18 months
次要结局
- vitamin b12(at 18 months)
- folate(at 18 months)
- homocysteine(at 18 months)