Overview

This trial is active, not recruiting.

Condition non-alcoholic steatohepatitis (nash)
Treatments vitamin d3, placebo
Phase phase 2
Sponsor University of Zurich
Start date January 2013
End date March 2016
Trial size 60 participants
Trial identifier NCT01571063, SASL 34

Summary

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

- Trial with medicinal product

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
vitamin d3
Vitamin D3, 2.100 IU/d p.o.
placebo
Placebo Tbl. p.o.
(Placebo Comparator)
vitamin d3
Vitamin D3, 2.100 IU/d p.o.
placebo
Placebo Tbl. p.o.

Primary Outcomes

Measure
Change from Baseline in serum alanine aminotransferase levels at week 48
time frame: Measurement at week 0 and week 48

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Principal investigator Beat Muellhaupt, Professor, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Zurich.