None listed
Conditions
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.
Interventions
Subjects will be asked to undergo exposure of approximately 15% of their body (i.e. the face, hands and arms) usually between 9.30am – 10am daily during the year, 5 days per week. During mid summer, these sessions will run between 8.30am – 9am. It is recognized that it may be practically difficult to achieve this exposure during the months of June – August and exposure during these winter months may be less effective, but it considered important the study should run continuously through the ye
Subjects will be asked to undergo exposure of approximately 15% of their body (i.e. the face, hands and arms) usually between 9.30am – 10am daily during the year, 5 days per week. During mid summer, these sessions will run between 8.30am – 9am. It is recognized that it may be practically difficult to achieve this exposure during the months of June – August and exposure during these winter months may be less effective, but it considered important the study should run continuously through the year for adherence purposes. Adherence will be enhanced via the appointment of ‘Sunlight Assistants’ in each intervention institution, who will be normally employed in that institution for other duties but reimbursed for 1.5 hours per day for their duties in the study. Calcium supplements (Caltrate, 600mg elemental calcium, orally, morning) will be administered to the group, daily. Individual and doctors consent are obtained from each resident. The hostels pharmacy distributes the calcium tablets in individual Webster packs. All participants will receive the medical care usually provided by other health professionals.
Sponsors
University of Sydney/ Northern Clinical School
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ambulant, likely to survive for more than 12 months, as assessed by the Implicit Review Tool employed in the FREE study
Exclusion criteria
Taking vitamin D or calcium supplements in the last 6 months, History of skin cancer in last three years
Outcome results
None listed