Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D
NCT ID: NCT01571063
Last Updated: 2016-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2013-01-31
2016-05-31
Brief Summary
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* Trial with medicinal product
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Vitamin D3
Vitamin D3
Vitamin D3, 2.100 IU/d p.o.
Placebo
Placebo Tbl. p.o.
Placebo
Vitamin D3
Vitamin D3, 2.100 IU/d p.o.
Placebo
Placebo Tbl. p.o.
Interventions
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Vitamin D3
Vitamin D3, 2.100 IU/d p.o.
Placebo
Placebo Tbl. p.o.
Eligibility Criteria
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Inclusion Criteria
* Elevated alanine aminotransferase level
* Diagnosis of definite or possible steatohepatitis (NASH)
Exclusion Criteria
* Serious diseases limiting life expectancy,
* Breast-feeding or pregnant women
* Unhealthy alcohol consumption
* Drug abuse or substitution therapy
* Use of vitamin preparations within the previous 6 months and during the study
* Weight loss \>5% within 12 months before study entry
* Newly diagnosed Diabetes mellitus requiring medical treatment within 12 months before study entry
* Use of anti-obesity drugs
* Previous or current hypercalcemia
* Chronic renal disease
18 Years
70 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Andreas Geier, Prof. MD
Role: STUDY_DIRECTOR
University Hospital Zurich, Division of Hepatology
Beat Muellhaupt, Professor, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zurich, Division of Gastroenterology and Hepatology
Locations
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University Hospital Zurich, Gastroenterology and Hepatology
Zurich, Canton of Zurich, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Countries
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Other Identifiers
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SASL 34
Identifier Type: -
Identifier Source: org_study_id
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