Vitamin D in Fatty Liver Disease

NCT ID: NCT04038853

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2019-04-01

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.

Conditions

Non-alcoholic Fatty Liver Disease; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin D

Intervention drug, containing 1,25-dihydroxy-vitamin D, comes in original packages as vials containing a total amount of 10 ml of clear solution. 5 drops accounting for 1000 IU of 1,25-dihydroxy-vitamin D will be administered orally on a daily basis.

Group Type: EXPERIMENTAL

1,25-Dihydroxyvitamin D

Intervention Type: DRUG

1,25-dihydroxy-vitamin D3 1000 IU orally daily for 12 months

Placebo

A placebo identical to the study intervention drug in all its characteristics (package, visual characteristics of the fluid, smell, and taste) will be administered in the same manner.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo identical to the study intervention drug

Interventions

1,25-Dihydroxyvitamin D

1,25-dihydroxy-vitamin D3 1000 IU orally daily for 12 months

Intervention Type: DRUG

Placebo

Placebo identical to the study intervention drug

Intervention Type: DRUG

Other Intervention Names

1,25-Dihydroxy-Cholecalciferol, Cholecalciferol, Vitamin D3

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rijeka

OTHER

Sponsor Role: collaborator

Pliva Hrvatska d.o.o.

UNKNOWN

Sponsor Role: collaborator

University Hospital Rijeka

OTHER

Sponsor Role: lead

Responsible Party

Ivana Mikolasevic

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivana Mikolasevic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Clinical Hospital Center Rijeka, University of Rijeka, Croatia

Other Identifiers

00000000-NAFLD

Identifier Type: -

Identifier Source: org_study_id