Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000658617
Ethics application status
Approved
Date submitted
20/09/2005
Date registered
19/10/2005
Date last updated
19/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin D Intervention To Prevent Falls and Fractures and To Promote Mental Well-Being.
Scientific title
Primary Care Prevention of Falls and Fractures in the Elderly by Annual Vitamin D Supplementation.
Secondary ID [1] 196 0
National Health and Medical Research Council (NHMRC): NHMRC 251682
Universal Trial Number (UTN)
Trial acronym
Vital D Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis and fractures 791 0
Mental well-being 792 0
Falls prevention 793 0
Condition category
Condition code
Musculoskeletal 866 866 0 0
Osteoporosis
Injuries and Accidents 867 867 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Double-Blind Randomised Placebo-Controlled Vitamin D InterventionTrial in which 2,300 women at high risk of fracture are randomised to receive treatment (500,000 IU ergocalciferol orally) or placebo every Autumn/Winter for three to five consecutive years. Participants are asked to complete a diary to record any falls and fractures. This information is collected monthly and confirmed. Participants also complete a validated mental well-being questionnaire at several timepoints throughout the study A subset of 126 women randomly selected undergo more intensive testing throughout the project. At regular intervals these women undergo basic clinical anthropometry, balance and muscle strength assessment; questionnaires to assess mental well-being and pathology testing.
Intervention code [1] 651 0
Prevention
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1110 0
Reduction in fracture rate [KERRIE SANDERS] between active and placebo arms
Timepoint [1] 1110 0
At completion of study.
Primary outcome [2] 1111 0
Time to 'fracture' comparison between the groups (Kaplein-Mier analysis).
Timepoint [2] 1111 0
At completion of study.
Secondary outcome [1] 2057 0
The study involves ongoing continuous ascertainment of falls and fractures sustained by participants.
Timepoint [1] 2057 0
This will be analysed at the completion of the study in 2008. The substudy tests are measured at baseline, one year and five-years with results analysed for differences in change from baseline between placebo and active arm groups.

Eligibility
Key inclusion criteria
Minimum age
70 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

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)
All participants have unique study number. These numbers are randomised to active or placebo arm of the study by department statistician using Minitab 11 software. Randomisation of numbers is given to clinicial trials pharmacist
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are assigned next study number upon study team having both their signed consent form and baseline serum calcium results within normal range. These numbers are randomised to active or placebo arm of the study by department statistician using Minitab 11 software. Randomisation of numbers is given to clinicial trials pharmacist.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/02/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 955 0
Government body
Name [1] 955 0
NHMRC project
Country [1] 955 0
Australia
Funding source category [2] 956 0
Government body
Name [2] 956 0
Commonwealth Dept of Health and Ageing
Country [2] 956 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 823 0
Hospital
Name [1] 823 0
Barwon Health
Address [1] 823 0
Country [1] 823 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2255 0
Barwon Health
Ethics committee address [1] 2255 0
Ethics committee country [1] 2255 0
Australia
Date submitted for ethics approval [1] 2255 0
Approval date [1] 2255 0
Ethics approval number [1] 2255 0
Ethics committee name [2] 2256 0
Geelong
Ethics committee address [2] 2256 0
Ethics committee country [2] 2256 0
Australia
Date submitted for ethics approval [2] 2256 0
Approval date [2] 2256 0
Ethics approval number [2] 2256 0

Summary
Brief summary
The study hypothesis is that an annual high dose (500,000 IU) of vitamin D2 will reduce the rate of falls and fracture compared with placebo in older women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36284 0
Address 36284 0
Country 36284 0
Phone 36284 0
Fax 36284 0
Email 36284 0
Contact person for public queries
Name 9840 0
Dr Kerrie Sanders
Address 9840 0
Department of Clinical and Biomedical Sciences
The University of Melbourne
Barwon Health
PO Box 281
Geelong VIC 3220
Country 9840 0
Australia
Phone 9840 0
+61 3 52267834
Fax 9840 0
+61 3 52267019
Email 9840 0
[email protected]
Contact person for scientific queries
Name 768 0
Dr Kerrie Sanders
Address 768 0
Department of Clinical and Biomedical Sciences
The University of Melbourne
Barwon Health
PO Box 281
Geelong VIC 3220
Country 768 0
Australia
Phone 768 0
+61 3 52267834
Fax 768 0
+61 3 52267019
Email 768 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.