Vitamin K deficiency in the pathogenesis of osteoporosis in primary biliary cirrhosis (PBC)
| ISRCTN | ISRCTN34566366 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34566366 |
| Protocol serial number | RBF 98X36 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Trent, UK |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 13/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Dr Dermot Gleeson
Scientific
Scientific
Department of Gastroenterology
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
| Phone | +44 (0)114 271 2832 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Gastroenterology
Sheffield
S10 2JF
United Kingdom
S10 2JF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
