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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-008275-34-GB

Enrollment

Registered

2009-07-06

Start date

2009-08-20

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Omacor Pharmaceutical Form: Capsule, soft CAS Number: 8000049754 Other descriptive name: OMEGA-3 TRIGLYCERIDES Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
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.; Secondary Objective: Secondary endpoints are ascertaining if: - Omega-3 fatty acids improve serum liver function tests - There is improvement in liver cell mitochondrial function with omega-3 supplementation. - Supplementation with omega-3 fatty acids affect health-related quality of life in NAFLD patients. ;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.	—

Measure

Time frame

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.; Secondary Objective: Secondary endpoints are ascertaining if: - Omega-3 fatty acids improve serum liver function tests - There is improvement in liver cell mitochondrial function with omega-3 supplementation. - Supplementation with omega-3 fatty acids affect health-related quality of life in NAFLD patients. ;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.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026