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

This study has been completed.
Information provided by (Responsible Party):
University of Zurich Identifier:
First received: March 28, 2012
Last updated: October 24, 2016
Last verified: October 2016

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

  • Trial with medicinal product

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Zurich:

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

Enrollment: 22
Study Start Date: January 2013
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01571063

University Hospital Zurich, Gastroenterology and Hepatology
Zurich, ZH, Switzerland, 8091
Kantonsspital St. Gallen
St. Gallen, Switzerland
Sponsors and Collaborators
University of Zurich
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

Responsible Party: University of Zurich Identifier: NCT01571063     History of Changes
Other Study ID Numbers: SASL 34
Study First Received: March 28, 2012
Last Updated: October 24, 2016

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 21, 2017