Clinical trial NCT04038853: Vitamin D in Fatty Liver Disease
Official title: Use of Vitamin D in Treatment of Non-Alcoholic Fatty Liver Disease Detected by Transient Elastography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-alcoholic Fatty Liver Disease
Vitamin D Deficiency
Lead sponsor: University Hospital Rijeka
Sponsor class: OTHER
Collaborators: name: University of Rijeka
name: Pliva Hrvatska d.o.o.
First posted: 2019-07-31
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the influence of vitamin D in reducing laboratory, elastographic (Fibroscan) and metabolic components of NAFLD. Half of the patients will receive vitamin D (Plivit D3) while the other half will receive placebo

Detailed description: In this study will participate patients who come to the regular ambulatory examinations (referred by gastroenterologists, or family physicians in the Department of Gastroenterology CHC Rijeka) and have one or more components of the metabolic syndrome (hypertension, diabetes, obesity, dyslipidemia).Nonalcoholic fatty liver disease will be defined by transient elastography (FibroScan, Echosens, Paris); Controlled Attenuation Parameter (CAP) for assesment of liver steatosis and Liver Stiffness Measurements (LSM) for liver fibrosis. In all patients other causes of chronic liver disease will be excluded; chronic viral hepatitis, autoimmune diseases and other metabolic liver diseases as well as use of drugs than can cause liver steatosis and fibrosis and alcoholic liver disease.

This study will include 450 patients. Taking into account the possible drop-out rate around 15% of the patients during the study period, a total of 400 patients will be randomized. Patients will be randomized into two groups. The first group will be consisted of the patients with NAFLD who will be receiving original medication during the 12 month period. The second group will be consisted of the patients with NAFLD who will be receiving placebo during the 12 months period, which will be identical to the original medication in its packaging and form.

After the 6 and 12 months of therapy in all patients will be evaluated: liver enzymes and metabolic laboratory parameters of NAFLD (insulin resistance, lipidogram and serum glucose), as well as the TE-CAP in order to evaluate the efficiency of Plivit D3 for the treatment of NAFLD.

Eligibility criteria: Inclusion Criteria:

* patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
* signed informed consent
* possibility to follow instruction and the protocol

Exclusion Criteria:

* chronic B or C hepatitis
* usage of hepatotoxic drugs in the period of 6 months before inclusion
* chronic kidney insufficiency (grade 4 and 5), hemodialysis
* any other chronic liver disease
* opioid dependancy
* any malignancy
* HIV seropositivity
* alcohol abuse
* pregnancy
* inability to follow the protocol

Primary outcomes:
measure: Elastographic parameter of steatosis
timeFrame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
measure: Elastographic parameter of fibrosis
timeFrame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Secondary outcomes:
measure: Aspartate transaminase
timeFrame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
measure: Alanine transaminase
timeFrame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
measure: Gamma-glutamyl transferase
timeFrame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
measure: Insuline Resistance
timeFrame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
measure: Total cholesterol
timeFrame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
measure: Low-density lipoprotein
timeFrame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
measure: High-density lipoprotein
timeFrame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
measure: Triglyceride
timeFrame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Other outcomes:
Locations:
Study officials:
affiliation: Department of Gastroenterology, Clinical Hospital Center Rijeka, University of Rijeka, Croatia
name: Ivana Mikolasevic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: