Dairy Product, Calcium & Vitamin D Supplementation and Cognitive-motor Function
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in spatiotemporal gait, and in particular in the variability of stride time
研究概览
简要总结
Gait and posture disorders are very common in subjects aged 65 and over, and result mainly from neuromuscular and cognitive disorders.
Many studies have shown that 1) vitamin D deficiency is very common in women aged 65 and over, 2) individuals with hypovitaminosis D have lower muscle, gait and executive performances and are more prone to fail than individuals with no hypovitaminosis D, 3) the intake of vitamin D combined or not with calcium may improve muscle strength and cognitive performance.
The investigators hypothesized that the daily intake of 2 yogurts containing 200 IU of vitamin D and 400 mg of calcium 1) can improve spatiotemporal gait parameters, posture and executive performance, 2) and that this improvement depends of the initial level of vitamin D deficiency.
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
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman aged 65 and over
- •To have hypovitaminosis D (i.e. serum 25-hydroxyvitamin D [25OHD] concentration ≤ 30ng/mL)
- •To have no hypercalcemia (defined as serum calcium concentration ≥ 2,65mmol/L)
- •Ability to walk a distance of 15 meters unaided
- •Ability to eat 2 yogurts per day
- •Memory complaint without cognitive decline
- •To have given and signed an informed consent to participate in the trial
- •To be affiliated to French Social Security
- •To have no vitamin D supplementation during inclusion
排除标准
- •Existence of dementia according to DSM-IV and NINCDS-ADRDA criteria and others cognitive disorders: untreated thyroid dysfunction, chronic ongoing ethylism, history of syphilis, stroke with sequelae, depressive symptomatology (Geriatric Depression Scale > 5/15)
- •Osteoarticular diseases of the lower members and / or spine altering the biomechanical characteristics of the body.
- •Vitamin D supplementation during inclusion
- •Contraindications to vitamin D
- •Unstable medical condition
- •Dairy allergy
- •Taste of dairy products not supported
- •Enrolment in another simultaneous clinical trial
- •Civil defense measures underway
- •Refusal to participate of the subject
结局指标
主要结局
Change in spatiotemporal gait, and in particular in the variability of stride time
时间窗: This outcome is assessed at baseline and 12 weeks after oral intake.
Stride time variability is measured with spatiotemporal analysis of walking
次要结局
- Change in executive performance(This outcome is assessed at baseline and 12 weeks after oral intake.)
- Change in posture(This outcome is assessed at baseline and 12 weeks after oral intake.)
- Change in other cognitive scores(These outcomes are assessed at baseline and 12 weeks after oral intake.)
- Change in grip strength(This outcome is assessed at baseline and 12 weeks after oral intake.)
- Change in the serum concentration of 25 OHD(This outcome is assessed at baseline and 12 weeks after oral intake.)
- Compliance to intervention(This outcome is assessed 12 weeks after oral intake.)