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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00322166




Registration number
NCT00322166
Ethics application status
Date submitted
4/05/2006
Date registered
5/05/2006
Date last updated
21/10/2009

Titles & IDs
Public title
The FREEDOM Study: a Randomised Controlled Trial of Sunlight and Calcium in Older People
Scientific title
A Randomised Controlled Trial of Sunlight and Calcium Supplementation to Reduce Vitamin D Deficiency and Falls in Older People in Residential Care
Secondary ID [1] 0 0
0512-240M
Secondary ID [2] 0 0
402639
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental Falls 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Sunlight
Other interventions - Sunlight and calcium
Other interventions - control

Active comparator: Group A, Sunlight - Participants in this arm are required to sit in the sun most days of the week for 15 minutes

Active comparator: Group B, sunlight and calcium - Participants in this group receive sunlight and a calcium supplement

No intervention: Group C - Control group


Other interventions: Sunlight
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.

Other interventions: 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.

Other interventions: control
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Falls
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Vit D
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Fractures
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Geriatric Depression
Timepoint [3] 0 0
1 year

Eligibility
Key inclusion criteria
* Aged 70 years or more
* Ambulant
* 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
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of skin cancer in last three years
* Taking vitamin D or calcium supplements
* Not ambulant

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2065 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00322166
Trial related presentations / publications
Sambrook PN, Cameron ID, Chen JS, Cumming RG, Durvasula S, Herrmann M, Kok C, Lord SR, Macara M, March LM, Mason RS, Seibel MJ, Wilson N, Simpson JM. Does increased sunlight exposure work as a strategy to improve vitamin D status in the elderly: a cluster randomised controlled trial. Osteoporos Int. 2012 Feb;23(2):615-24. doi: 10.1007/s00198-011-1590-5. Epub 2011 Mar 3.
Public notes

Contacts
Principal investigator
Name 0 0
Philip Sambrook, MD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00322166