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

This study is currently recruiting participants.

Verified March 2013 by University of Zurich

Sponsor:

Information provided by (Responsible Party):

University of Zurich

ClinicalTrials.gov Identifier:

NCT01571063

First received: March 28, 2012

Last updated: March 4, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 28, 2012

Last Updated Date

March 4, 2013

Start Date ^ICMJE

January 2013

Estimated Primary Completion Date

March 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from Baseline in serum alanine aminotransferase levels at week 48 [ Time Frame: Measurement at week 0 and week 48 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01571063 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief Summary

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

Trial with medicinal product

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Non-alcoholic Steatohepatitis (NASH)

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Vitamin D3
Interventions:
- Drug: Vitamin D3
- Drug: Placebo
Placebo Comparator: Placebo
Interventions:
- Drug: Vitamin D3
- Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2016

Estimated Primary Completion Date

March 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Fabian Tay, MD

+41 (0)44 255 11 11

fabian.tay@usz.ch

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01571063

Other Study ID Numbers ^ICMJE

SASL 34

Has Data Monitoring Committee

Not Provided

Responsible Party

University of Zurich

Study Sponsor ^ICMJE

University of Zurich

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University of Zurich

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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