Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Non-alcoholic Steatohepatitis Fatty Liver |
Drug: Omega 3 Fish Oil supplements Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH) |
- 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 ] [ Designated as safety issue: No ]
- Measurement of anthropometric indices (weight, BMI, waist circumference) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Hepatic fat content measured by magnetic resonance imaging [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 64 |
| Study Start Date: | March 2007 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Virginia | |
| University of Virginia School of Medicine | |
| Charlottesville, Virginia, United States, 22908 | |
| Principal Investigator: | Stephen H Caldwell, MD | University of Virginia |
More Information
No publications provided
| Responsible Party: | Stephen H. Caldwell, MD, University of Virginia Health System, Division of Gastroenterology |
| ClinicalTrials.gov Identifier: | NCT00681408 History of Changes |
| Other Study ID Numbers: | 12442, R21AT002901, IRB # 12442, GCRC: SHC003, Grant # 5R21AT2901-2 |
| Study First Received: | May 19, 2008 |
| Last Updated: | August 6, 2010 |
| Health Authority: | United States: Food and Drug Administration United States: Federal Government |
Keywords provided by University of Virginia:
|
Steatohepatitis NASH NAFLD omega 3 fatty acids Exercise conditioning |
Additional relevant MeSH terms:
|
Fatty Liver Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013