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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01571063
First received: March 28, 2012
Last updated: October 24, 2016
Last verified: October 2016

March 28, 2012
October 24, 2016
January 2013
May 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 ]
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
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Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters.

  • Trial with medicinal product
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Interventional
Phase 2
Allocation: Randomized
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
May 2016
May 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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01571063
SASL 34
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University of Zurich
University of Zurich
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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
October 2016

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