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ISRCTN
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ISRCTN83409867
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DOI
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10.1186/ISRCTN83409867
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Primary Care Prevention of Falls and Fractures in the elderly by Annual Vitamin D Supplementation
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Scientific title
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Acronym
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Vital D Study
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Serial number at source
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NHMRC 251682
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Study hypothesis
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That an annual high-dose (500,000 IU) of 25-hydroxyvitamin D will reduce the rate of fractures and falls compared to placebo in older women.
Please note that as of 11/11/09 the ethics, interventions and secondary outcome fields of this trial have been updated.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Added 11/11/09:
1. Barwon Health Human Research Ethics Committee (ref: 02/60)
2. University of Melbourne Human Research Ethics Committee (HREC) (ref: 0200700)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Fractures, osteoporosis and falls.
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Participants - inclusion criteria
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1. Female
2. Over 70 years old
3. High risk of falls or fracture
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Participants - exclusion criteria
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1. Hypercalcemia
2. Bone-trophic medications
3. Renal disease
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Anticipated start date
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01/04/2003
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Anticipated end date
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30/09/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2300
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Interventions
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Current information as of 11/11/09:
500,000 IU cholecalciferol or placebo
Initial information at time of registration
500,000 IU ergocalciferol or placebo annually.
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Primary outcome measure(s)
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Reduction of fracture rate in active arm compared to placebo.
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Secondary outcome measure(s)
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1. Reduction in rate of falls
2. Improvement in mental well-being
3. Duration of independent residency
4. Reduction in total healthcare utilisation (added 11/11/09)
Substudy group are tested for various parameters of muscle strength, balance, gait and mobility.
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Sources of funding
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1. National Health and Medical Research Council (NHMRC) (Australia) (refs: 251682, 509109 and 509310)
2. Commonwealth Department of Health and Ageing RC (Australia) (ref: 100505 8)
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Trial website
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Publications
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1. 2009 results of recruitment strategies in http://www.ncbi.nlm.nih.gov/pubmed/19930724
2. 2010 main results in http://www.ncbi.nlm.nih.gov/pubmed/20460620
3. 2011 mental well-being results in http://www.ncbi.nlm.nih.gov/pubmed/21525520
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Contact name
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Prof
Geoffrey
Nicholson
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Address
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Department of Clinical and Biomedical Sciences
P.O. Box 281
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City/town
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Geelong
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Zip/Postcode
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3220
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Country
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Australia
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Tel
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+61 (0)3 52267762
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Fax
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+61 (0)3 52222420
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Email
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geoffn@barwonhealth.org.au
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Sponsor
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The University of Melbourne (Australia)
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Address
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Grattan Street
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City/town
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Parkville
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Zip/Postcode
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3010
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Country
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Australia
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Sponsor website:
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http://www.unimelb.edu.au
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Date applied
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19/08/2005
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Last edited
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01/08/2011
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Date ISRCTN assigned
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13/09/2005
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