Primary Care Prevention of Falls and Fractures in the elderly by Annual Vitamin D Supplementation
| ISRCTN | ISRCTN83409867 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83409867 |
| Protocol serial number | NHMRC 251682 |
| Sponsor | The University of Melbourne (Australia) |
| Funders | National Health and Medical Research Council (NHMRC) (Australia) (refs: 251682, 509109 and 509310), Commonwealth Department of Health and Ageing RC (Australia) (ref: 100505 8) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Reduction of fracture rate in active arm compared to placebo. |
| Key secondary outcome measure(s) |
1. Reduction in rate of falls |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/02/2016: Publication reference added.
