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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01571063
First received: March 28, 2012
Last updated: September 4, 2014
Last verified: September 2014

March 28, 2012
September 4, 2014
January 2013
March 2016   (final data collection date for primary outcome measure)
Change from Baseline in serum alanine aminotransferase levels at week 48 [ Time Frame: Measurement at week 0 and week 48 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01571063 on ClinicalTrials.gov Archive Site
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Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D
Not Provided

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

  • Trial with medicinal product
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-alcoholic Steatohepatitis (NASH)
  • Drug: Vitamin D3
    Vitamin D3, 2.100 IU/d p.o.
  • Drug: Placebo
    Placebo Tbl. p.o.
  • Experimental: Vitamin D3
    Interventions:
    • Drug: Vitamin D3
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Vitamin D3
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Fabian Tay, MD +41 (0)44 255 11 11 fabian.tay@usz.ch
Switzerland
 
NCT01571063
SASL 34
Not Provided
University of Zurich
University of Zurich
Not Provided
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
University of Zurich
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP