Vitamin K deficiency in the pathogenesis of osteoporosis in primary biliary cirrhosis (PBC)

ISRCTN	ISRCTN34566366
DOI	https://doi.org/10.1186/ISRCTN34566366
Secondary identifying numbers	RBF 98X36

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

Dr Dermot Gleeson
Scientific

Department of Gastroenterology
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Phone	+44 (0)114 271 2832

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Scientific title
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	31/03/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	60
Key inclusion criteria	Sixty out-patients with PBC will be recruited from the Royal Hallamshire Hospital Liver Service.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/1998
Date of final enrolment	31/03/2003

Department of Gastroenterology

Sheffield
S10 2JF
United Kingdom

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive Trent, UK

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan