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Primary Care Prevention of Falls and Fractures in the elderly by Annual Vitamin D Supplementation
ISRCTN ISRCTN83409867
DOI 10.1186/ISRCTN83409867
ClinicalTrials.gov identifier
EudraCT number
Public title Primary Care Prevention of Falls and Fractures in the elderly by Annual Vitamin D Supplementation
Scientific title
Acronym Vital D Study
Serial number at source NHMRC 251682
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval 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)
Study design Randomised controlled trial
Countries of recruitment Australia
Disease/condition/study domain Fractures, osteoporosis and falls.
Participants - inclusion criteria 1. Female
2. Over 70 years old
3. High risk of falls or fracture
Participants - exclusion criteria 1. Hypercalcemia
2. Bone-trophic medications
3. Renal disease
Anticipated start date 01/04/2003
Anticipated end date 30/09/2008
Status of trial Completed
Patient information material
Target number of participants 2300
Interventions 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.
Primary outcome measure(s) Reduction of fracture rate in active arm compared to placebo.
Secondary outcome measure(s) 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.
Sources of funding 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)
Trial website
Publications 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
Contact name Prof  Geoffrey  Nicholson
  Address Department of Clinical and Biomedical Sciences
P.O. Box 281
  City/town Geelong
  Zip/Postcode 3220
  Country Australia
  Tel +61 (0)3 52267762
  Fax +61 (0)3 52222420
  Email geoffn@barwonhealth.org.au
Sponsor The University of Melbourne (Australia)
  Address Grattan Street
  City/town Parkville
  Zip/Postcode 3010
  Country Australia
  Sponsor website: http://www.unimelb.edu.au
Date applied 19/08/2005
Last edited 01/08/2011
Date ISRCTN assigned 13/09/2005
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