The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease

Phase 3

Completed

• Conditions: Non Alcoholic Fatty Liver Disease
• Interventions: Drug: Omacor; Drug: lactose tablet

• Registration Number: NCT01277237
• Lead Sponsor: University of Edinburgh

Brief Summary

There is preliminary evidence that Omega 3, a compound naturally found in fish oil, reduces the amount of fat stored in the liver and improves liver function. The purpose of this study is to see whether this observation is correct.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Status Verified: 2010-12
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-14
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2014-01-22
• Last Update Posted: 2014-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• a diagnosis of non-alcoholic fatty liver disease
• fatty infiltration on ultrasound
• abnormal serum liver function tests.

Exclusion Criteria

• 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
• on anticoagulants (antiplatelets are permitted)
• severe heart failure (NYHA class IV)
• pregnancy/ lactation
• age under 18 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omacor	Omacor	-
Lactose tablet	lactose tablet	-

Primary Outcome Measures

Name	Time	Method
Liver appearance on ultrasound	6 months	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.

Secondary Outcome Measures

Name	Time	Method
hepatocyte mitochondrial function	6 months	heptocyte mitochondrial function will be measured by breath testing following 6 months of omega-3 supplementation
Liver function tests	6 months	the effect of omega-3 fatty acids on serum liver function tests will be assessed following 6 months of treatment.
Health-related Quality of Life	6 months	Health related quality of life scores will be compared with baseline following 6 months of omega-3 supplementation

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Lothian, United Kingdom