Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
May 27, 2015 updated by: Stephen Caldwell, MD, University of Virginia
Nonalcoholic steatohepatitis (NASH) occurs in 2-3% of the US population and carries a 15-20% chance of progression to cirrhosis.
It is closely associated with obesity, hyperlipidemia and insulin resistance.
Therapy usually includes recommendations to increase exercise and to begin weight reducing diets but these goals are variably achieved and their relative effects in conjunction with pharmacological intervention have not been well defined.
Moreover, these lifestyle changes can confound results of treatment trials if not quantified through conditioning testing and measures of body fat.
Polyunsaturated fatty acids, especially formulation rich in omega-3, are widely accepted and endorsed in the medical community for their beneficial effects on hyperlipidemia and coronary disease risk reduction.
Recent data suggests that omega-3 fatty acids ameliorate hepatic steatosis in humans and in animal models of NASH by reducing hepatic fat content.
We hypothesize that a one year course of omega-3 fatty acid (3gm/day) will produce improvement in NASH histological injury independent of changes in weight (BMI) or degree of conditioning measured by the lactate threshold.
The effects of the supplement will be compared to a placebo group and controlled for these lifestyle changes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 2
- 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
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia School of Medicine
-
-
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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- NASH with NAS (NASH Activity Score) of >4 evident on a biopsy performed within 6 months of enrollment.
- Age 21 years or older.
- BMI 25 or greater.
- Ability to provide informed consent.
Exclusion Criteria:
- Cirrhosis evident clinically or on biopsy.
- Secondary forms of NASH such as that seen with bariatric surgery or medication induced from such medications as methotrexate, amiodarone, tamoxifen, corticosteroids.
- Current or past history of diabetes or hyperlipidemia requiring specific drug therapy (see below).
- Current use of a weight loss medicine, such as a 'fat-burner' or similar agent
- Alcohol consumption > 30 g/day, currently or for more than 3 consecutive months within 5 years.
- Other liver disease (hepatitis C,B, Wilson's, autoimmune, ct-1-antitrypsin and hemochromatosis or HIV
- Pregnancy or unwillingness to use an effective form of birth control for women of child bearing years.
- Renal insufficiency (creatinine > 2), symptomatic coronary, peripheral or neurovascular disease, symptomatic heart failure or advanced respiratory disease requiring oxygen therapy.
- Inability to provide informed consent.
- Any condition in the opinion of the primary investigator that would contraindicate the patient's participation.
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: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Omega 3 recipient arm
|
Subjects in this arm will receive 3 grams daily Omega 3 fish oil supplements
Other Names:
|
|
Placebo Comparator: Placebo
Placebo fish oil
|
Fish oil placebo pills
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS).
Time Frame: approximately 12 months from enrollment
|
approximately 12 months from enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measurement of anthropometric indices (weight, BMI, waist circumference)
Time Frame: 12 months
|
12 months
|
|
Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill)
Time Frame: 12 months
|
12 months
|
|
Hepatic fat content measured by magnetic resonance imaging
Time Frame: 12 months
|
12 months
|
|
Changes in fasting plasma lipids, red cell fatty acid content, changes in anti-hyperlipidemia requirements, insulin sensitivity, and markers of inflammation including tumor necrosis factor and C-reactive protein
Time Frame: 12 mos
|
12 mos
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen H Caldwell, MD, University of Virginia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2007
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
May 19, 2008
First Submitted That Met QC Criteria
May 20, 2008
First Posted (Estimate)
May 21, 2008
Study Record Updates
Last Update Posted (Estimate)
May 29, 2015
Last Update Submitted That Met QC Criteria
May 27, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12442
- R21AT002901 (U.S. NIH Grant/Contract)
- IRB # 12442
- GCRC: SHC003
- Grant # 5R21AT2901-2
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.