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

NCT ID: NCT01571063

Last Updated: 2016-10-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-05-31

Brief Summary

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

* Trial with medicinal product

Detailed Description

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Conditions

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Non-alcoholic Steatohepatitis (NASH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D3

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

Vitamin D3, 2.100 IU/d p.o.

Placebo

Intervention Type DRUG

Placebo Tbl. p.o.

Placebo

Group Type PLACEBO_COMPARATOR

Vitamin D3

Intervention Type DRUG

Vitamin D3, 2.100 IU/d p.o.

Placebo

Intervention Type DRUG

Placebo Tbl. p.o.

Interventions

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Vitamin D3

Vitamin D3, 2.100 IU/d p.o.

Intervention Type DRUG

Placebo

Placebo Tbl. p.o.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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SASL 34

Identifier Type: -

Identifier Source: org_study_id

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