A Randomised Controlled Trial of Sunlight and Calcium Supplementation to Reduce Vitamin D Deficiency and Falls in Older People in Residential Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Falls
研究概览
简要总结
The proposed study will determine the effect of a public health strategy (ie. increased sun light exposure and increased calcium intake) to reduce falls in older people in residential care using a randomised trial. The primary hypothesis of the trial is that increased appropriate sun light exposure will reduce falls, improve 25 hydroxy vitamin D (25OHD) levels and lower parathyroid hormone (PTH) levels. Secondary hypotheses are that the intervention will reduce accelerated bone turnover, reduce fractures, improve motor function and improve mood.
详细描述
Specific Aims and Objectives
The proposed trial will determine the effect of a public health strategy (ie increased sun light exposure and increased calcium intake) to reduce falls and fractures in older people living in residential care in a randomised trial. The primary hypothesis of the trial is that increased appropriate sun light exposure will reduce falls, improve 25OHD levels and lower PTH levels. Secondary hypotheses are that the intervention will reduce accelerated bone turnover, reduce fractures, improve motor function and improve mood.
Study Design
A randomised, controlled, multi-centre trial will be conducted over 12 months. Cluster randomization will be performed in hostels (low care residential aged care facilities) that agree to participate.
Participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 70 years or more
- •Likely to survive for more than 12 months, as assessed by the Implicit Review Tool employed in the FREE study
- •Not taking vitamin D or calcium supplements
- •No history of skin cancer in last three years
排除标准
- •History of skin cancer in last three years
- •Taking vitamin D or calcium supplements
- •Not ambulant
研究组 & 干预措施
Group A, Sunlight
Participants in this arm are required to sit in the sun most days of the week for 15 minutes
干预措施: Sunlight (Other)
Group B, sunlight and calcium
Participants in this group receive sunlight and a calcium supplement
干预措施: Sunlight and calcium (Other)
Group C
Control group
干预措施: control (Other)
结局指标
主要结局
Falls
时间窗: 1 year
次要结局
- Vit D(1 year)
- Fractures(1 year)
- Geriatric Depression(1 year)