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

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

* Trial with medicinal product

Completed

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Key information

Conditions

Non-alcoholic Steatohepatitis (NASH) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Zurich, Gastroenterology and Hepatology, Zurich, Canton of Zurich, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Drug

Vitamin D3, 2.100 IU/d p.o.

Placebo

Drug

Placebo Tbl. p.o.

Primary outcomes

Change from Baseline in serum alanine aminotransferase levels at week 48

Time frame: Measurement at week 0 and week 48

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Apr 4, 2012
Registry last updated: Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed