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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 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: February 21, 2014
Last verified: February 2014
  Purpose

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

  • Trial with medicinal product

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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571063

Contacts
Contact: Fabian Tay, MD +41 (0)44 255 11 11 fabian.tay@usz.ch

Locations
Switzerland
University Hospital Zurich, Gastroenterology and Hepatology Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Fabian Tay, MD         
Sub-Investigator: Yéri Haller, MD         
Kantonsspital St. Gallen Not yet recruiting
St. Gallen, Switzerland
Contact: David Semela, MD         
Sub-Investigator: David Semela, MD         
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
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01571063     History of Changes
Other Study ID Numbers: SASL 34
Study First Received: March 28, 2012
Last Updated: February 21, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 23, 2014