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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01277237
First Posted: January 14, 2011
Last Update Posted: January 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh
  Purpose
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.

Condition Intervention Phase
Non Alcoholic Fatty Liver Disease Drug: Omacor Drug: lactose tablet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • hepatocyte mitochondrial function [ Time Frame: 6 months ]
    heptocyte mitochondrial function will be measured by breath testing following 6 months of omega-3 supplementation

  • 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


Enrollment: 50
Study Start Date: September 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omacor Drug: Omacor
Active comparator: omacor 4g/day
Other Names:
  • Omega-3
  • N-3 Fatty acids
Placebo Comparator: Lactose tablet Drug: lactose tablet
placebo: lactose tablet 4g/day
Other Name: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277237


Locations
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom, EH164SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Peter C Hayes, MD PhD Royal Infirmary of Edinburgh
  More Information

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01277237     History of Changes
Other Study ID Numbers: Edin2008-008275-34
2008-008275-34 ( EudraCT Number )
First Submitted: January 13, 2011
First Posted: January 14, 2011
Last Update Posted: January 23, 2014
Last Verified: December 2010

Keywords provided by University of Edinburgh:
Non alcoholic fatty liver disease

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases