Text Size

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

This study is currently recruiting participants.
Verified March 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01571063
First received: March 28, 2012
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

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
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: March 4, 2013
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 May 23, 2013