Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000748213
Ethics application status
Approved
Date submitted
4/08/2009
Date registered
28/08/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A targeted community program of vitamin D treatment to reduce hospital admissions for falls, fractures and other disorders
Scientific title
A randomised controlled placebo-controlled study to evaluate the effects of vitamin D treatment on reducing hospital admissions for falls, fractures and other disorders in elderly women
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in the elderly 243451 0
Fractures in the elderly 243452 0
Condition category
Condition code
Musculoskeletal 239886 239886 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
150,000 IU vitamin D (cholecalciferol) taken orally as 3 capsules at three clinic visits three months apart; lifestyle advice on physical activity and calcium intake given at baseline through an information sheet administered by trained research assistants
Intervention code [1] 237068 0
Treatment: Drugs
Intervention code [2] 237069 0
Lifestyle
Comparator / control treatment
Three identical placebo capsules made of lactose taken orally at three clinic visits three months apart; lifestyle advice on physical activity and calcium intake given at baseline through an information sheet administered by trained research assistants
Control group
Placebo

Outcomes
Primary outcome [1] 240511 0
Falls events in general as recorded by subjects on a condition and medication logbook and reviewed at clinic visits three months apart by trained research assistants
Timepoint [1] 240511 0
At 9 months after intervention commencement
Primary outcome [2] 240512 0
Falls events (as recorded by subjects on a condition and medication logbook and reviewed at clinic visits three months apart by trained research assistants) in winter/spring
Timepoint [2] 240512 0
At 9 months after intervention commencement
Primary outcome [3] 240513 0
Falls events (as recorded by subjects on a condition and medication logbook and reviewed at clinic visits three months apart by trained research assistants) in those with baseline serum 25-hydroxyvitamin D (25(OH)D) levels less than 60 nmol/L.
Timepoint [3] 240513 0
At 9 months after intervention commencement
Secondary outcome [1] 257068 0
Serum 25-hydroxyvitamin D (25OHD) levels as assessed by the Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) method
Timepoint [1] 257068 0
At 3, 6 and 9 months after intervention commencement
Secondary outcome [2] 257069 0
Adverse events including vascular diseases, cancer, hypocalcaemia and renal calculus as recorded by subjects on a condition and medication logbook and reviewed at clinic visits three months apart by trained research assistants
Timepoint [2] 257069 0
At 9 months after intervention commencement
Secondary outcome [3] 257070 0
Direct costs of the intervention and the costs of falls related adverse events
Timepoint [3] 257070 0
At 9 months after intervention commencement
Secondary outcome [4] 257071 0
Mobility function as assessed by the Timed Up and Go test and hand grip strength as assessed by a hand dynamometer
Timepoint [4] 257071 0
At 3, 6 and 9 months after intervention commencement

Eligibility
Key inclusion criteria
1. Females age over 70;
2. a) Registered with a General Practitioner (GP) attached to the practices selected for the study or
b) Registered with a General Practitioner and able to contact her General Practitioner in Perth;
3. Likely to be able to attend their General Practitioner practice or Sir Charles Gairdner Hospital for four study visits over nine months.
Minimum age
70 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Consuming a vitamin D supplement either in isolation or as part of a combination treatment of greater than 200 IU per day, eg. Actonel combi +D or Fosamax plus;
2. A mini mental state score of less than 24;
3. Individuals who in the investigators opinion would not be suitable for the study.

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)
Subjects numbers were allocated by the pharmacy who has no contact with study participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
660
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237444 0
Government body
Name [1] 237444 0
Western Australia Department of Health
Country [1] 237444 0
Australia
Primary sponsor type
Individual
Name
Professor RL Prince
Address
Bone and Calcium Research Group, School of Medicine and Pharmacology, University of Western Australia, Department of Endocrinology and Diabetes, 1st Floor C Block, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 236934 0
University
Name [1] 236934 0
University of Western Australia
Address [1] 236934 0
Stirling Highway, Crawley, WA 6009
Country [1] 236934 0
Australia
Secondary sponsor category [2] 236935 0
Hospital
Name [2] 236935 0
Sir Charles Gairdner Hospital
Address [2] 236935 0
Hospital Ave, Nedlands, WA 6009
Country [2] 236935 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239575 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 239575 0
1st Floor E Block, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA 6009
Ethics committee country [1] 239575 0
Australia
Date submitted for ethics approval [1] 239575 0
Approval date [1] 239575 0
09/10/2008
Ethics approval number [1] 239575 0
2008-103

Summary
Brief summary
This is a nine-month randomised controlled study to evaluate the effects of vitamin D 150,000 IU per three months on risk of falling, serum vitamin D levels, mobility function and muscle strength in women aged 70 years and over at a community setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30008 0
Address 30008 0
Country 30008 0
Phone 30008 0
Fax 30008 0
Email 30008 0
Contact person for public queries
Name 13255 0
Professor Richard L Prince
Address 13255 0
Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, WA 6009
Country 13255 0
Australia
Phone 13255 0
+61 8 9346 3488
Fax 13255 0
+61 8 9346 1317
Email 13255 0
[email protected]
Contact person for scientific queries
Name 4183 0
Professor Richard L Prince
Address 4183 0
Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, WA 6009
Country 4183 0
Australia
Phone 4183 0
+61 8 9346 3488
Fax 4183 0
+61 8 9346 1317
Email 4183 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
SourceTitleYear of PublicationDOI
EmbaseLong-term proton pump inhibitor therapy and falls and fractures in elderly women: A prospective cohort study.2014https://dx.doi.org/10.1002/jbmr.2279
N.B. These documents automatically identified may not have been verified by the study sponsor.