Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
13/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dermot Gleeson

ORCID ID

Contact details

Department of Gastroenterology
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
+44 (0)114 271 2832

Additional identifiers

EudraCT 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Osteoporosis

Intervention

i. Vitamin K supplementation
ii. No vitamin K supplementation

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin K

Primary outcome measures

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 trial start date

01/10/1998

Overall trial end date

31/03/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Sixty out-patients with PBC will be recruited from the Royal Hallamshire Hospital Liver Service.

Participant type

Patient

Age group

Not Specified

Gender

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

United Kingdom

Trial 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

http://www.doh.gov.uk

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes