Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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/ct2/show/NCT00322166
Trial related presentations / publications
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