Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000089437
Ethics application status
Approved
Date submitted
15/01/2007
Date registered
25/01/2007
Date last updated
26/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Freedom study (Falls Risk Epidemiology:Effect of Vitamin D on skeletal Outcomes and other Measures)
Scientific title
A randomised controlled trial on the effect of sunlight and calcium to reduce vitamin D deficiency in older people in residential care
Secondary ID [1] 334 0
ClinicalTrials.gov: NCT00322166
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in older people living in residential care 1585 0
Fractures in older people living in residential care 1586 0
Vitamin D deficiency in older people living in residential care 1587 0
Calcium supplement 3277 0
Condition category
Condition code
Musculoskeletal 1688 1688 0 0
Osteoporosis
Injuries and Accidents 1689 1689 0 0
Fractures
Musculoskeletal 3442 3442 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1557 0
Treatment: Other
Intervention code [2] 3018 0
Prevention
Comparator / control treatment
Subjects in the intervention groups 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. 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. All participants will receive the medical care usually provided by other health professionals.
Control group
Active

Outcomes
Primary outcome [1] 2339 0
Falls.
Timepoint [1] 2339 0
Assessed after the last cluster recruited has reached 12 months follow-up. Falls will be recorded by regular monthly visits to hostels for 12 months including review of incident reports and clinical record review.
Secondary outcome [1] 4072 0
motor function measures related to falls risk (static balance, sit to stand test)
Timepoint [1] 4072 0
assessed at baseline and 12 months
Secondary outcome [2] 4073 0
Quadriceps strength and body sway
Timepoint [2] 4073 0
assessed in at baseline, 6 month follow-up and 12 month follow-up
Secondary outcome [3] 4074 0
Fractures will be determined by regular visits to hostels and validated by x-ray reports.
Timepoint [3] 4074 0
monthly for 12 months
Secondary outcome [4] 4075 0
The effects of the intervention on mood will be assessed using the Geriatric Depression Scale
Timepoint [4] 4075 0
baseline and at 12month follow-up

Eligibility
Key inclusion criteria
ambulant, likely to survive for more than 12 months, as assessed by the Implicit Review Tool employed in the FREE study
Minimum age
70 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Taking vitamin D or calcium supplements in the last 6 months, History of skin cancer in last three years

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)
The person who determined a subject was eligible fro inclusion in the trial is unaware to which group the subject would be allocated as randomization of the hostel would occur after all eligible residents were approached and recruitment at that hostel had finished. Allocation of a hostel was concealed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1830 0
Government body
Name [1] 1830 0
National Health and Medical Research Council (NHMRC)
Country [1] 1830 0
Australia
Primary sponsor type
University
Name
University of Sydney/ Northern Clinical School
Address
Northern Clinical School
Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 1649 0
None
Name [1] 1649 0
Nil
Address [1] 1649 0
Country [1] 1649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3426 0
Royal North Shore Hospital
Ethics committee address [1] 3426 0
Ethics committee country [1] 3426 0
Australia
Date submitted for ethics approval [1] 3426 0
Approval date [1] 3426 0
Ethics approval number [1] 3426 0
0512-240M
Ethics committee name [2] 3427 0
University of Sydney
Ethics committee address [2] 3427 0
Ethics committee country [2] 3427 0
Australia
Date submitted for ethics approval [2] 3427 0
Approval date [2] 3427 0
Ethics approval number [2] 3427 0

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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27491 0
Address 27491 0
Country 27491 0
Phone 27491 0
Fax 27491 0
Email 27491 0
Contact person for public queries
Name 10746 0
Dr Cindy Kok
Address 10746 0
Department of Rheumatology
Royal North Shore Hospital
Level 4 Building 35
Pacific Highway
St Leonards NSW 2065
Country 10746 0
Australia
Phone 10746 0
+61 2 99267840
Fax 10746 0
+61 2 99061859
Email 10746 0
[email protected]
Contact person for scientific queries
Name 1674 0
Professor Phil Sambrook
Address 1674 0
Department of Rheumatology
Royal North Shore Hospital
Level 4 Building 35
Pacific Highway
St Leonards NSW 2065
Country 1674 0
Australia
Phone 1674 0
+61 2 99267281
Fax 1674 0
+61 2 99061859
Email 1674 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.