Primary Care Prevention of Falls and Fractures in the elderly by Annual Vitamin D Supplementation
| ISRCTN | ISRCTN83409867 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83409867 |
| Secondary identifying numbers | NHMRC 251682 |
- Submission date
- 19/08/2005
- Registration date
- 13/09/2005
- Last edited
- 09/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Geoffrey Nicholson
Scientific
Scientific
Department of Clinical and Biomedical Sciences
P.O. Box 281
Geelong
3220
Australia
| Phone | +61 (0)3 52267762 |
|---|---|
| geoffn@barwonhealth.org.au |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Primary Care Prevention of Falls and Fractures in the elderly by Annual Vitamin D Supplementation |
| Study acronym | Vital D Study |
| Study objectives | 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. |
| Ethics approval(s) | 1. Barwon Health Human Research Ethics Committee (ref: 02/60) 2. University of Melbourne Human Research Ethics Committee (HREC) (ref: 0200700) |
| Health condition(s) or problem(s) studied | Fractures, osteoporosis and falls. |
| Intervention | Current interventions as of 11/11/2009: 500,000 IU cholecalciferol or placebo Previous interventions: 500,000 IU ergocalciferol or placebo annually |
| Intervention type | Supplement |
| Primary outcome measure | 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 11/11/2009) Substudy group are tested for various parameters of muscle strength, balance, gait and mobility. |
| Overall study start date | 01/04/2003 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target number of participants | 2300 |
| Key inclusion criteria | 1. Female 2. Over 70 years old 3. High risk of falls or fracture |
| Key exclusion criteria | 1. Hypercalcemia 2. Bone-trophic medications 3. Renal disease |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- Australia
Study participating centre
Department of Clinical and Biomedical Sciences
Geelong
3220
Australia
3220
Australia
Sponsor information
The University of Melbourne (Australia)
University/education
University/education
Grattan Street
Parkville
3010
Australia
| Website | http://www.unimelb.edu.au |
|---|---|
"ROR" |
https://ror.org/01ej9dk98 |
Funders
Funder type
Research council
National Health and Medical Research Council (NHMRC) (Australia) (refs: 251682, 509109 and 509310)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Commonwealth Department of Health and Ageing RC (Australia) (ref: 100505 8)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results of recruitment strategies | 25/11/2009 | Yes | No | |
| Results article | main results | 12/05/2010 | Yes | No | |
| Results article | mental well-being results | 01/05/2011 | Yes | No | |
| Results article | results | 01/07/2014 | Yes | No | |
| Results article | results | 01/03/2015 | Yes | No |
Editorial Notes
09/02/2016: Publication reference added.
