Vitamin D in Fatty Liver Disease

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04038853
• Other study ID #: 00000000-NAFLD
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2015
• Est. completion date: April 1, 2019

Study information

• Verified date: July 2019
• Source: University Hospital Rijeka
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: April 1, 2019
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Vitamin D Deficiency

Intervention

Drug:
• 1,25-Dihydroxyvitamin D
1,25-dihydroxy-vitamin D3 1000 IU orally daily for 12 months
• Placebo
Placebo identical to the study intervention drug

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Rijeka	Pliva Hrvatska d.o.o., University of Rijeka

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elastographic parameter of steatosis	Change of elastographic parameter of steatosis (Controlled Attenuation Parameter; CAP) during the 6 and 12 months period	Week 0 - initiation; after 6 months; and after 12 months (end of study)
Primary	Elastographic parameter of fibrosis	Change of elastographic parameter of fibrosis (liver stiffness measurements; LSM) during the 6 and 12 months period	Week 0 - initiation; after 6 months; and after 12 months (end of study)
Secondary	Aspartate transaminase	Change in liver enzyme aspartate transaminase (AST) serum levels in the period of 6 and 12 months. Normal range = 11-38 IU/L.	Week 0 - initiation; after 6 months; and after 12 months (end of study)
Secondary	Alanine transaminase	Change in liver enzyme alanine transaminase (ALT) serum levels in the period of 6 and 12 months. Normal range = 12-48 IU/L.	Week 0 - initiation; after 6 months; and after 12 months (end of study)
Secondary	Gamma-glutamyl transferase	Change in liver enzyme gamma-glutamyl transferase (GGT) serum levels in the period of 6 and 12 months. Normal range = 11-55 IU/L.	Week 0 - initiation; after 6 months; and after 12 months (end of study)
Secondary	Insuline Resistance	Change in insulin resistance defined by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR; normal range = 0.5 to 1.4) score in the period of 6 and 12 months	Week 0 - initiation; after 6 months; and after 12 months (end of study)
Secondary	Total cholesterol	Change in total cholesterol serum levels in the period of 6 and 12 months	Week 0 - initiation; after 6 months; and after 12 months (end of study)
Secondary	Low-density lipoprotein	Change in low-density lipoprotein (LDL) serum levels in the period of 6 and 12 months	Week 0 - initiation; after 6 months; and after 12 months (end of study)
Secondary	High-density lipoprotein	Change in high-density lipoprotein (HDL) serum levels in the period of 6 and 12 months	Week 0 - initiation; after 6 months; and after 12 months (end of study)
Secondary	Triglyceride	Change in triglyceride (TG) serum levels in the period of 6 and 12 months	Week 0 - initiation; after 6 months; and after 12 months (end of study)