The Effect of Omega-3 Fatty Acids on Non-Alcoholic Fatty Liver Disease

Phase 1

• Conditions: on-alcoholic fatty liver disease; MedDRA version: 9.1 Level: LLT Classification code 10029530 Term: Non-alcoholic fatty liver

• Registration Number: EUCTR2008-008275-34-GB
• Lead Sponsor: HS Lothian

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-06
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

A diagnosis of non-alcoholic fatty liver disease.
Abnormal liver function tests.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria include: any other identified cause of chronic liver disease, the prescription of medication which would cause non-alcoholic fatty liver disease (e.g. tamoxifen), already taking supplementary fish oil, alcohol intake of >20g/day for women, >40g/ day for men, known allergy to fish oil or corn oil, on anticoagulants (antiplatelets are permitted), severe heart failure (NYHA class IV), pregnancy/ lactation, or age under 18 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To ascertain if omega-3 fatty acids improve the ultrasound appearance of the liver, particularly the liver fat content, in patients with non-alcoholic fatty liver disease.;<br> Secondary Objective: Secondary endpoints are ascertaining if:<br> - Omega-3 fatty acids improve serum liver function tests<br> - There is improvement in liver cell mitochondrial function with omega-3 supplementation.<br> - Supplementation with omega-3 fatty acids affect health-related quality of life in NAFLD patients.<br> ;Primary end point(s): The primary endpoint is improvement in grading on ultrasound assessment at six months. Liver brightness and posterior attenuation on ultrasound has previously been shown to correlate significantly with fat scores on liver biopsy.