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

Non-alcoholic Steatohepatitis (NASH) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571063
• Other study ID #: SASL 34
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2012
• Last updated: October 24, 2016
• Start date: January 2013
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

• Trial with medicinal product

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis (NASH)

Intervention

Drug:
• Vitamin D3
Vitamin D3, 2.100 IU/d p.o.
• Placebo
Placebo Tbl. p.o.

Locations

Country	Name	City	State
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	University Hospital Zurich, Gastroenterology and Hepatology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in serum alanine aminotransferase levels at week 48		Measurement at week 0 and week 48	No