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Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01571063
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:

Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters.

  • Trial with medicinal product

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis (NASH) Drug: Vitamin D3 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitamin D3 Drug: Vitamin D3
Vitamin D3, 2.100 IU/d p.o.

Drug: Placebo
Placebo Tbl. p.o.
Placebo Comparator: Placebo Drug: Vitamin D3
Vitamin D3, 2.100 IU/d p.o.

Drug: Placebo
Placebo Tbl. p.o.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in serum alanine aminotransferase levels at week 48 [ Time Frame: Measurement at week 0 and week 48 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with 25-OH vitamin D insufficiency
  • Elevated alanine aminotransferase level
  • Diagnosis of definite or possible steatohepatitis (NASH)

Exclusion criteria:

  • Cirrhosis, present liver disease other than NASH
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571063


Locations
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Switzerland
University Hospital Zurich, Gastroenterology and Hepatology
Zurich, ZH, Switzerland, 8091
Kantonsspital St. Gallen
St. Gallen, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
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Study Director: Andreas Geier, Prof. MD University Hospital Zurich, Division of Hepatology
Principal Investigator: Beat Muellhaupt, Professor, MD University Hospital Zurich, Division of Gastroenterology and Hepatology
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01571063    
Other Study ID Numbers: SASL 34
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Vitamin D
Cholecalciferol
Vitamins
Liver Diseases
 Digestive System Diseases
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents