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Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT00681408
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : May 29, 2015
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Stephen Caldwell, MD, University of Virginia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Fatty Liver Drug: Omega 3 Fish Oil supplements Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
Study Start Date : March 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Active Comparator: Omega 3 recipient arm Drug: Omega 3 Fish Oil supplements
Subjects in this arm will receive 3 grams daily Omega 3 fish oil supplements
Other Name: Fish Oil capsules

Placebo Comparator: Placebo
Placebo fish oil
Drug: Placebo
Fish oil placebo pills

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Measurement of anthropometric indices (weight, BMI, waist circumference) [ Time Frame: 12 months ]
  2. Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill) [ Time Frame: 12 months ]
  3. Hepatic fat content measured by magnetic resonance imaging [ Time Frame: 12 months ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. NASH with NAS (NASH Activity Score) of >4 evident on a biopsy performed within 6 months of enrollment.
  2. Age 21 years or older.
  3. BMI 25 or greater.
  4. Ability to provide informed consent.

Exclusion Criteria:

  1. Cirrhosis evident clinically or on biopsy.
  2. Secondary forms of NASH such as that seen with bariatric surgery or medication induced from such medications as methotrexate, amiodarone, tamoxifen, corticosteroids.
  3. Current or past history of diabetes or hyperlipidemia requiring specific drug therapy (see below).
  4. Current use of a weight loss medicine, such as a 'fat-burner' or similar agent
  5. Alcohol consumption > 30 g/day, currently or for more than 3 consecutive months within 5 years.
  6. Other liver disease (hepatitis C,B, Wilson's, autoimmune, ct-1-antitrypsin and hemochromatosis or HIV
  7. Pregnancy or unwillingness to use an effective form of birth control for women of child bearing years.
  8. Renal insufficiency (creatinine > 2), symptomatic coronary, peripheral or neurovascular disease, symptomatic heart failure or advanced respiratory disease requiring oxygen therapy.
  9. Inability to provide informed consent.
  10. Any condition in the opinion of the primary investigator that would contraindicate the patient's participation.

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): NCT00681408

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United States, Virginia
University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Stephen H Caldwell, MD University of Virginia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stephen Caldwell, MD, Professor, Department of Gastroenterology, University of Virginia
ClinicalTrials.gov Identifier: NCT00681408    
Other Study ID Numbers: 12442
R21AT002901 ( U.S. NIH Grant/Contract )
IRB # 12442
Grant # 5R21AT2901-2
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015
Keywords provided by Stephen Caldwell, MD, University of Virginia:
omega 3 fatty acids
Exercise conditioning
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases