The effects of purified n-3 fatty acids on serum biomarkers and cardiovascular risk markers in a randomized placebo controlled trial in patients with non alcoholic fatty liver disease - Treatment of non alcoholic fatty liver disease with n-3 fatty acids

Phase 1

• Conditions: on alcoholic fatty liver disease (NAFLD). This fatty liver disease may progress to a chronic condition that sometimes deteriorates further to cirrhosis and even liver carcinoma. To date there is no licensed treatment for this condition and therefore it is important to test potential treatments for NAFLD.; MedDRA version: 14.1 Level: LLT Classification code 10031743 Term: Other chronic nonalcoholic liver disease System Organ Class: 10019805 - Hepatobiliary disorders

• Registration Number: EUCTR2008-003766-26-GB
• Lead Sponsor: Southampton University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-21
• Study Completion: 2018-11-29
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 103

Inclusion Criteria

1. Steatohepatitis diagnosed on normal clinical grounds including in most cases liver biopsy and assessed by Kleiner scoring system to assess severity, with no known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B & C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).

2. Steatosis diagnosed by ultrasound, CT or magnetic resonance imaging who also have either diabetes and/or features of the metabolic syndrome, and without evidence of known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B & C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).

Liver biopsy or liver scan will be within 3 years of recruitment to the study.

Age: men & women >18 years. Alcohol consumption <35 units / week for women <50 units / week for men) .

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 10

Exclusion Criteria

Decompensated acute or chronic liver disease, or harmful drinking (>35u/week in women >50 u /week in men). Pregnancy. Lactating women. Hypersensitivity to Omacor, soya or any of the excipients.

Study & Design

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