A pilot study to examine the effect of vitamin C on bone turnover and antioxidant levels in postmenopausal women with low bone density.
| ISRCTN | ISRCTN44380631 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44380631 |
| Secondary identifying numbers | N0112150254 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 16/12/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sanjeev Patel
Scientific
Scientific
Epsom and St Helier NHS Trust
Department of Rheumatology
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Does Vitamin C (a natural antioxidant) reduces bone turnover in women with postmenopausal osteoporosis? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Osteoporosis |
| Intervention | Open label, randomised Study |
| Intervention type | Other |
| Primary outcome measure | Changes in biochemical markers and antioxidant levels from baseline to end of study in vitamin C group. Group compared to controls |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2004 |
| Completion date | 01/11/2005 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Postmenopausal women with low bone density. Consenting healthy postmenopausel women with low bone density; osteopenia (Tscore<-1.0) as defined by the WHO 1994. |
| Key exclusion criteria | On treatment for osteroporosis or taking any bone active drugs (e.g. oestrogens, steroids, vitamin D) or known to be suffering from diseases which can affect the skeleton such as renal or liver failure, malabsorption, thyrotoxicosis). |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/11/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Epsom and St Helier NHS Trust
Carshalton
SM5 1AA
United Kingdom
SM5 1AA
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
Epsom and St Helier University Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding
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 |
