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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01571063

Enrollment

Registered

2012-04-04

Start date

2013-01-31

Completion date

2016-05-31

Last updated

2016-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Steatohepatitis (NASH)

Brief summary

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

Interventions

DRUGVitamin D3

Vitamin D3, 2.100 IU/d p.o.

DRUGPlacebo

Placebo Tbl. p.o.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026