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

This study has been completed.
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01277237
First received: January 13, 2011
Last updated: January 22, 2014
Last verified: December 2010
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01277237     History of Changes
Other Study ID Numbers: Edin2008-008275-34, 2008-008275-34
Study First Received: January 13, 2011
Last Updated: January 22, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 19, 2014