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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN34566366 |
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Date of registration:
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23/01/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Vitamin K deficiency in the pathogenesis of osteoporosis in primary biliary cirrhosis (PBC)
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Scientific title:
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Date of first enrolment:
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01/10/1998 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN34566366 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Prevention)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Dermot
Gleeson |
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Address:
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Department of Gastroenterology
Royal Hallamshire Hospital
Glossop Road
S10 2JF
Sheffield
United Kingdom |
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Telephone:
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+44 (0)114 271 2832 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Sixty out-patients with PBC will be recruited from the Royal Hallamshire Hospital Liver Service.
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Osteoporosis
Musculoskeletal Diseases
Osteoporosis and primary biliary cirrhosis
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Intervention(s)
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i. Vitamin K supplementation
ii. No vitamin K supplementation
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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RBF 98X36
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Source(s) of Monetary Support
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NHS Executive Trent, UK
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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