Trial from ANZCTR


Trial ID ACTRN12605000658617
Trial Status: Registered
Date Submitted: 20/09/2005
Date Registered: 19/10/2005
Retrospectively registered

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Public title Vitamin D Intervention To Prevent Falls and Fractures and To Promote Mental Well-Being.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Primary Care Prevention of Falls and Fractures in the Elderly by Annual Vitamin D Supplementation.
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Secondary ID [1] 196 0
National Health and Medical Research Council (NHMRC): NHMRC 251682
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UTN
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Trial acronym Vital D Study
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Health condition(s) or problem(s) studied:
Osteoporosis and fractures 791 0
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Mental well-being 792 0
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Falls prevention 793 0
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Condition category: Condition code:
Musculoskeletal Osteoporosis
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866 866 0 0
Injuries and Accidents Fractures
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867 867 0 0

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Descriptions 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.
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Intervention Code:
Prevention 651 0
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Comparator / control treatment Placebo
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Control group Placebo
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Primary Outcome: Reduction in fracture rate [KERRIE SANDERS] between active and placebo arms 1110 0
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Timepoint: At completion of study. 1110 0
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Primary Outcome: Time to 'fracture' comparison between the groups (Kaplein-Mier analysis). 1111 0
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Timepoint: At completion of study. 1111 0
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Secondary Outcome: The study involves ongoing continuous ascertainment of falls and fractures sustained by participants. 2057 0
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Timepoint: 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. 2057 0
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Key inclusion criteria
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Minimum age 70 Years
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Maximum age Not stated
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Gender Females
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Healthy volunteers? No
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Key exclusion criteria
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the 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
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 3 / Phase 4
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Anticipated date of first participant enrolment 24/02/2003
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 2300
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Government body 955 0
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Name: NHMRC project 955 0
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Address: 955 0
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Country: Australia 955 0
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Funding Source: Government body 956 0
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Name: Commonwealth Dept of Health and Ageing 956 0
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Address: 956 0
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Country: Australia 956 0
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Primary Sponsor University
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Name: The University of Melbourne
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Country: Australia
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Secondary Sponsor: Hospital 823 0
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Name: Barwon Health 823 0
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Address: 823 0
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Country: Australia 823 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Barwon Health 2255 0
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Address: 2255 0
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Country: Australia 2255 0
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Approval Date: 2255 0
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Submitted Date: 2255 0
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HREC: 2255 0
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Ethics Committee name: Geelong 2256 0
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Address: 2256 0
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Country: Australia 2256 0
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Approval Date: 2256 0
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Submitted Date: 2256 0
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HREC: 2256 0
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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.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Kerrie Sanders
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Address: Department of Clinical and Biomedical Sciences The University of Melbourne Barwon Health PO Box 281 Geelong VIC 3220
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Country: Australia
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Tel: +61 3 52267834
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Fax: +61 3 52267019
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Email: kerrie@barwonhealth.org.au
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Contact person for scientific queries
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Name: Dr Kerrie Sanders
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Address: Department of Clinical and Biomedical Sciences The University of Melbourne Barwon Health PO Box 281 Geelong VIC 3220
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Country: Australia
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Tel: +61 3 52267834
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Email: kerrie@barwonhealth.org.au
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Addition Cancer fields
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