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

January 22, 2014 updated by: University of Edinburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH164SA
        • Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Lactose tablet
Drug: lactose tablet
placebo: lactose tablet 4g/day
Other Names:
  • Placebo
Active Comparator: Omacor
Drug: Omacor
Active comparator: omacor 4g/day
Other Names:
  • Omega-3
  • N-3 Fatty acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver appearance on ultrasound
Time Frame: 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.
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

Investigators

  • Principal Investigator: Peter C Hayes, MD PhD, Royal Infirmary of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 13, 2011

First Submitted That Met QC Criteria

January 13, 2011

First Posted (Estimate)

January 14, 2011

Study Record Updates

Last Update Posted (Estimate)

January 23, 2014

Last Update Submitted That Met QC Criteria

January 22, 2014

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Edin2008-008275-34
  • 2008-008275-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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