The FREEDOM Study: a Randomised Controlled Trial of Sunlight and Calcium in Older People
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Randomised Controlled Trial of Sunlight and Calcium Supplementation to Reduce Vitamin D Deficiency and Falls in Older People in Residential Care|
- Falls [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Vit D [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Fractures [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Geriatric Depression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Group A, Sunlight
Participants in this arm are required to sit in the sun most days of the week for 15 minutes
Subjects in the intervention groups will be asked to undergo exposure of approximately 15% of their body (ie the face, hands and arms) usually between 9.30am - 10am daily during the year, 5 days per week.
Active Comparator: Group B, sunlight and calcium
Participants in this group receive sunlight and a calcium supplement
Other: Sunlight and calcium
Subjects in the intervention groups will be asked to undergo exposure of approximately 15% of their body (ie the face, hands and arms) usually between 9.30am - 10am daily during the year, 5 days per week. In the calcium and sunlight arm, calcium supplements (Caltrate, 600mg elemental calcium, Whitehall) will be administered to the whole group via the Blister/ Webster packs.
No Intervention: Group C
Subjects in the control group will be provided with a brochure about vitamin D deficiency and how to treat it. They will receive their usual routine care and nutrition.
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|Australia, New South Wales|
|Royal North Shore Hospital|
|Sydney, New South Wales, Australia, 2065|
|Principal Investigator:||Philip Sambrook, MD||University of Sydney|