- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01277237
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
-
-
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
|
placebo: lactose tablet 4g/day
Other Names:
|
Active Comparator: Omacor
|
Active comparator: omacor 4g/day
Other Names:
|
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
Collaborators
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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