Trial | NCT04038853  Report issue

Title

Vitamin D in Fatty Liver Disease
Use of Vitamin D in Treatment of Non-Alcoholic Fatty Liver Disease Detected by Transient Elastography

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    360
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
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.
Study Started
Dec 01
2015
Primary Completion
Feb 01
2017
Study Completion
Apr 01
2019
Last Update
Jul 31
2019

Drug 1,25-Dihydroxyvitamin D

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

  • Other names: 1,25-Dihydroxy-Cholecalciferol, Cholecalciferol, Vitamin D3

Drug Placebo

Placebo identical to the study intervention drug

Vitamin D Experimental

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.

Placebo Placebo Comparator

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.

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
No Results Posted