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

University of Zurich (UZH)

Status and phase: Completed; Phase 2

Conditions: Non-alcoholic Steatohepatitis (NASH)

Treatments: Drug: Placebo; Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01571063

SASL 34

Details and patient eligibility

About

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

• Trial with medicinal product

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

Vitamin D3

Experimental group

Treatment:

Drug: Vitamin D3

Drug: Placebo

Placebo

Placebo Comparator group

Treatment:

Drug: Vitamin D3

Drug: Placebo