Vitamin D in Fatty Liver Disease

University Hospital Rijeka

Status and phase: Completed; Phase 4

Conditions: Vitamin D Deficiency; Non-alcoholic Fatty Liver Disease

Treatments: Drug: 1,25-Dihydroxyvitamin D; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04038853

00000000-NAFLD

Details and patient eligibility

About

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

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Description:

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.

Treatment:

Drug: 1,25-Dihydroxyvitamin D

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo