Non-alcoholic Steatohepatitis (NASH)Phase 2NCT01571063
Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D
A Phase 2 study testing Vitamin D3 in people with Non-alcoholic Steatohepatitis (NASH), run by University of Zurich at 2 sites in Switzerland.
Trial summary
Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters. Trial with medicinal product Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis (NASH)
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2013to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with 25-OH vitamin D insufficiency
- Elevated alanine aminotransferase level
- Diagnosis of definite or possible steatohepatitis (NASH)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Kantonsspital St. Gallen
Sankt Gallen
University Hospital Zurich, Gastroenterology and Hepatology
Zurich, Canton of Zurich, 8091
About this study
Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters.
- Trial with medicinal product
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Being tested
- Vitamin D3, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Vitamin D3, 2.100 IU/d p.o.
PlaceboDrug
Placebo Tbl. p.o.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | Not described Receives: Drug: Vitamin D3; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Vitamin D3; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in serum alanine aminotransferase levels at week 48
Measured: Measurement at week 0 and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startJan 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Geier, Prof. MD, Study director, University Hospital Zurich, Division of HepatologyBeat Muellhaupt, Professor, MD, Principal investigator, University Hospital Zurich, Division of Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571063
- Sponsor's protocol ID
- SASL 34
- Status last verified
- Oct 2016
- First submitted
- 28 Mar 2012
- Last updated
- 25 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D
- ClinicalTrials.gov ID
- NCT01571063
- Acronym / sponsor ID
- SASL 34
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters.
- Trial with medicinal product
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Drug: Vitamin D3, Drug: Placebo |
| Placebo | Placebo comparator | Drug: Vitamin D3, Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with 25-OH vitamin D insufficiency
- Elevated alanine aminotransferase level
- Diagnosis of definite or possible steatohepatitis (NASH)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Vitamin D3, 2.100 IU/d p.o. | Drug | Placebo, Vitamin D3 |
| PlaceboPlacebo Tbl. p.o. | Drug | Placebo, Vitamin D3 |
Primary outcome
Change from Baseline in serum alanine aminotransferase levels at week 48
Time frame: Measurement at week 0 and week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Geier, Prof. MD study director
University Hospital Zurich, Division of Hepatology
Beat Muellhaupt, Professor, MD principal investigator
University Hospital Zurich, Division of Gastroenterology and Hepatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with Non-alcoholic Steatohepatitis (NASH), run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in serum alanine aminotransferase levels at week 48 (time frame: Measurement at week 0 and week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.