Treatment of Non-alcoholic Steatohepatitis (NASH) Patient... | NCT01571063

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

NCT01571063

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Oct 25, 2016Estimated

Enrollment

22Actual

Phase

Phase 2

Conditions

Non-alcoholic Steatohepatitis (NASH)

Interventions

Vitamin D3
Placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Mar 28, 2012

First Submission Date that Met QC Criteria

Apr 2, 2012

First Posted Date

Apr 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2016

Last Update Posted Date

Oct 25, 2016Estimated

Description Module

Brief Summary

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

Trial with medicinal product

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D3	Experimental		Drug: Vitamin D3 Drug: Placebo
Placebo	Placebo Comparator		Drug: Vitamin D3 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D3	Drug	Vitamin D3, 2.100 IU/d p.o.	Placebo Vitamin D3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in serum alanine aminotransferase levels at week 48		Measurement at week 0 and week 48

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Geier, Prof. MD	University Hospital Zurich, Division of Hepatology	Study Director
Beat Muellhaupt, Professor, MD	University Hospital Zurich, Division of Gastroenterology and Hepatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Gastroenterology and Hepatology		Zurich	Canton of Zurich	8091	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided