Condition category
Musculoskeletal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
16/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sanjeev Patel

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0112150254

Study information

Scientific title

Acronym

Study hypothesis

Does Vitamin C (a natural antioxidant) reduces bone turnover in women with postmenopausal osteoporosis?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal Diseases: Osteoporosis

Intervention

Open label, randomised Study

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/11/2004

Overall trial end date

01/11/2005

Reason abandoned

Objectives no longer viable

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Not provided at time of registration

Participant 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).

Recruitment start date

01/11/2004

Recruitment end date

01/11/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Epsom and St Helier University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes