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

Epsom and St Helier NHS Trust
Department of Rheumatology
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesDoes 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) studiedMusculoskeletal Diseases: Osteoporosis
InterventionOpen label, randomised Study
Intervention typeOther
Primary outcome measureChanges in biochemical markers and antioxidant levels from baseline to end of study in vitamin C group. Group compared to controls
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/2004
Completion date01/11/2005
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaPostmenopausal 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 criteriaOn 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 enrolment01/11/2004
Date of final enrolment01/11/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Epsom and St Helier NHS Trust
Carshalton
SM5 1AA
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan