Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D
This trial is active, not recruiting.
|Condition||non-alcoholic steatohepatitis (nash)|
|Treatments||vitamin d3, placebo|
|Sponsor||University of Zurich|
|Start date||January 2013|
|End date||March 2016|
|Trial size||60 participants|
|Trial identifier||NCT01571063, SASL 34|
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|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change from Baseline in serum alanine aminotransferase levels at week 48
time frame: Measurement at week 0 and week 48
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
|Principal investigator||Beat Muellhaupt, Professor, MD|
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