A Randomised Controlled Trial of Sunlight and Calcium Supplementation to Reduce Vitamin D Deficiency and Falls in Older People in Residential Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sydney
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Falls
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •History of skin cancer in last three years
- •Taking vitamin D or calcium supplements
- •Not ambulant
Outcomes
Primary Outcomes
Falls
Time Frame: 1 year
Secondary Outcomes
- Vit D(1 year)
- Fractures(1 year)
- Geriatric Depression(1 year)