Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
RBF 98X36
Study information
Scientific title
Acronym
Study hypothesis
To determine the vitamin K status and measure bone mineral density loss over 12 months in 60 patients presenting with primary biliary cirrhosis. To determine the effects of vitamin K therapy on longitudinal bone mineral density and biochemical markers of bone metabolism in primary biliary cirrhosis patients.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Prevention
Patient information sheet
Condition
Osteoporosis
Intervention
i. Vitamin K supplementation
ii. No vitamin K supplementation
Intervention type
Supplement
Primary outcome measure
Should Vitamin K supplementation be found to alter the course of bone loss in PBC patients it would provide a very cost effective therapeutic intervention. The research may have additional implications for healthcare provision in other areas of metabolic bone disease.
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/10/1998
Overall study end date
31/03/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Sixty out-patients with PBC will be recruited from the Royal Hallamshire Hospital Liver Service.
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/1998
Recruitment end date
31/03/2003
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Department of Gastroenterology
Sheffield
S10 2JF
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
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
Government
Funder name
NHS Executive Trent, UK
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|