Primary prevention of fractures in the elderly: randomised controlled trial (RCT) of an annual injection of vitamin D in the prevention of hip and other non-vertebral fractures
| ISRCTN | ISRCTN13267529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13267529 |
| Secondary identifying numbers | SEO148 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 17/09/2010
- 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
Not provided at time of registration
Contact information
Dr Helen Smith
Scientific
Scientific
Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| Phone | +44 (0)2380 797740 |
|---|---|
| hes@soton.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Scientific title | |
| Study hypothesis | Do annual intramuscular injections of 300,000 IU of vitamin D given in the autumn reduce the risk of hip and other non-vertebral fractures sustained by men and women aged 75 yrs & over in the general practice population |
| Ethics approval(s) | Approved by the South West Multi-centre Research Ethics Committee (MREC/98/6/51) |
| Condition | Injury, occupational diseases, poisoning: Musculoskeletal injury |
| Intervention | Injection containing 300,000 IU Vitamin D or placebo injection given annually over three years |
| Intervention type | Supplement |
| Primary outcome measure | Incidence of hip fractures, non-vertebral fractures, falls |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2000 |
| Overall study end date | 01/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 10000 |
| Participant inclusion criteria | 10,000 men and women over 75 years from a general practice population living independently in own homes or sheltered accommodation |
| Participant exclusion criteria | 1. History of renal failure or stones 2. Hypercalcaemia 3. Active cancer 4. Medication history of oestrogen or biphosphonate within last 3 years 5. People taking daily oral vitamin supplements containing 400 IU or more of Vitamin D |
| Recruitment start date | 01/09/2000 |
| Recruitment end date | 01/03/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Primary Medical Care
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South East (UK)
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 | 01/12/2007 | Yes | No |
