Back to resultsThe Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease
Primary Purpose
Non Alcoholic Fatty Liver Disease
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Omacor
lactose tablet
Sponsored by
About this trial
This is an interventional treatment trial for Non Alcoholic Fatty Liver Disease focused on measuring Non alcoholic fatty liver disease
Eligibility 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.
Sites / Locations
- Royal Infirmary of Edinburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Omacor
Lactose tablet
Arm Description
Outcomes
Primary Outcome Measures
Liver appearance on ultrasound
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
the effect of omega-3 fatty acids on serum liver function tests will be assessed following 6 months of treatment.
hepatocyte mitochondrial function
heptocyte mitochondrial function will be measured by breath testing following 6 months of omega-3 supplementation
Health-related Quality of Life
Health related quality of life scores will be compared with baseline following 6 months of omega-3 supplementation
Full Information
NCT ID
NCT01277237
First Posted
January 13, 2011
Last Updated
January 22, 2014
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
1. Study Identification
Unique Protocol Identification Number
NCT01277237
Brief Title
The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease
Official Title
The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Fatty Liver Disease
Keywords
Non alcoholic fatty liver disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omacor
Arm Type
Active Comparator
Arm Title
Lactose tablet
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Omacor
Other Intervention Name(s)
Omega-3, N-3 Fatty acids
Intervention Description
Active comparator: omacor 4g/day
Intervention Type
Drug
Intervention Name(s)
lactose tablet
Other Intervention Name(s)
Placebo
Intervention Description
placebo: lactose tablet 4g/day
Primary Outcome Measure Information:
Title
Liver appearance on ultrasound
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Liver function tests
Description
the effect of omega-3 fatty acids on serum liver function tests will be assessed following 6 months of treatment.
Time Frame
6 months
Title
hepatocyte mitochondrial function
Description
heptocyte mitochondrial function will be measured by breath testing following 6 months of omega-3 supplementation
Time Frame
6 months
Title
Health-related Quality of Life
Description
Health related quality of life scores will be compared with baseline following 6 months of omega-3 supplementation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C Hayes, MD PhD
Organizational Affiliation
Royal Infirmary of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Lothian
ZIP/Postal Code
EH164SA
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease
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