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

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT01571063

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Trial with medicinal product

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

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Change from Baseline in serum alanine aminotransferase levels at week 48 [Measurement at week 0 and week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Gastroenterology and Hepatology	Zurich	ZH	Switzerland	8091
2	Kantonsspital St. Gallen	St. Gallen		Switzerland

Sponsors and Collaborators

University of Zurich

Investigators

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