Contact information
Type
Scientific
Primary contact
Prof Geoffrey Nicholson
ORCID ID
Contact details
Department of Clinical and Biomedical Sciences
P.O. Box 281
Geelong
3220
Australia
+61 (0)3 52267762
geoffn@barwonhealth.org.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NHMRC 251682
Study information
Scientific title
Acronym
Vital D Study
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Fractures, osteoporosis and falls.
Intervention
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.
Intervention type
Supplement
Phase
Not Specified
Drug names
25-hydroxyvitamin D
Primary outcome measures
Reduction of fracture rate in active arm compared to placebo.
Secondary outcome measures
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.
Overall trial start date
01/04/2003
Overall trial end date
30/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Female
2. Over 70 years old
3. High risk of falls or fracture
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
2300
Participant exclusion criteria
1. Hypercalcemia
2. Bone-trophic medications
3. Renal disease
Recruitment start date
01/04/2003
Recruitment end date
30/09/2008
Locations
Countries of recruitment
Australia
Trial participating centre
Department of Clinical and Biomedical Sciences
Geelong
3220
Australia
Sponsor information
Organisation
The University of Melbourne (Australia)
Sponsor details
Grattan Street
Parkville
3010
Australia
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
National Health and Medical Research Council (NHMRC) (Australia) (refs: 251682, 509109 and 509310)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Australia
Funder name
Commonwealth Department of Health and Ageing RC (Australia) (ref: 100505 8)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Results of recruitment strategies
Sanders KM, Stuart AL, Merriman EN, Read ML, Kotowicz MA, Young D, Taylor R, Blair-Holt I, Mander AG, Nicholson GC, Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study., BMC Med Res Methodol, 2009, 9, 78, doi: 10.1186/1471-2288-9-78.
-
Main results
Sanders KM, Stuart AL, Williamson EJ, Simpson JA, Kotowicz MA, Young D, Nicholson GC, Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial., JAMA, 2010, 303, 18, 1815-1822, doi: 10.1001/jama.2010.594.
-
Sanders KM, Stuart AL, Williamson EJ, Jacka FN, Dodd S, Nicholson G, Berk M, Annual high-dose vitamin D3 and mental well-being: randomised controlled trial., Br J Psychiatry, 2011, 198, 5, 357-364, doi: 10.1192/bjp.bp.110.087544.