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Completed

NCT Number: NCT01277237

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

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.

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Key information

Conditions

Non Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH164SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OMACOR

Drug

Active comparator: omacor 4g/day

Other names: Omega-3, N-3 Fatty acids

lactose tablet

Drug

placebo: lactose tablet 4g/day

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. hepatocyte mitochondrial function

    Time frame: 6 months

    heptocyte mitochondrial function will be measured by breath testing following 6 months of omega-3 supplementation

  3. 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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 14, 2011
Registry last updated
Jan 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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