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 |
| Protocol serial number | N0112150254 |
| Sponsor | Department of Health |
| Funders | Epsom and St Helier University Hospitals NHS Trust (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Changes in biochemical markers and antioxidant levels from baseline to end of study in vitamin C group. Group compared to controls |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/11/2005 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| 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
- United Kingdom
- England
Study participating centre
Epsom and St Helier NHS Trust
Carshalton
SM5 1AA
United Kingdom
SM5 1AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
