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

Primary Purpose

Non-alcoholic Steatohepatitis (NASH)

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Steatohepatitis (NASH)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Zurich, Gastroenterology and Hepatology
  • Kantonsspital St. Gallen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in serum alanine aminotransferase levels at week 48

Secondary Outcome Measures

Full Information

First Posted
March 28, 2012
Last Updated
October 24, 2016
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01571063
Brief Title
Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

5. Study Description

Brief Summary
Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters. Trial with medicinal product

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Steatohepatitis (NASH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Intervention Description
Vitamin D3, 2.100 IU/d p.o.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Tbl. p.o.
Primary Outcome Measure Information:
Title
Change from Baseline in serum alanine aminotransferase levels at week 48
Time Frame
Measurement at week 0 and week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Geier, Prof. MD
Organizational Affiliation
University Hospital Zurich, Division of Hepatology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Beat Muellhaupt, Professor, MD
Organizational Affiliation
University Hospital Zurich, Division of Gastroenterology and Hepatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Gastroenterology and Hepatology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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