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 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 trial start date
01/11/2004
Overall trial end date
01/11/2005
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list