Back to resultsOmega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
Primary Purpose
Non-alcoholic Steatohepatitis, Fatty Liver
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omega 3 Fish Oil supplements
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Steatohepatitis focused on measuring Steatohepatitis, NASH, NAFLD, omega 3 fatty acids, Exercise conditioning
Eligibility Criteria
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.
Sites / Locations
- University of Virginia School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Omega 3 recipient arm
Placebo
Arm Description
Placebo fish oil
Outcomes
Primary Outcome Measures
The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS).
Secondary Outcome Measures
Measurement of anthropometric indices (weight, BMI, waist circumference)
Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill)
Hepatic fat content measured by magnetic resonance imaging
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
Full Information
NCT ID
NCT00681408
First Posted
May 19, 2008
Last Updated
May 27, 2015
Sponsor
University of Virginia
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00681408
Brief Title
Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
Official Title
Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Steatohepatitis, Fatty Liver
Keywords
Steatohepatitis, NASH, NAFLD, omega 3 fatty acids, Exercise conditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega 3 recipient arm
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo fish oil
Intervention Type
Drug
Intervention Name(s)
Omega 3 Fish Oil supplements
Other Intervention Name(s)
Fish Oil capsules
Intervention Description
Subjects in this arm will receive 3 grams daily Omega 3 fish oil supplements
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Fish oil placebo pills
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Measurement of anthropometric indices (weight, BMI, waist circumference)
Time Frame
12 months
Title
Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill)
Time Frame
12 months
Title
Hepatic fat content measured by magnetic resonance imaging
Time Frame
12 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen H Caldwell, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia School of Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25195547
Citation
Argo CK, Patrie JT, Lackner C, Henry TD, de Lange EE, Weltman AL, Shah NL, Al-Osaimi AM, Pramoonjago P, Jayakumar S, Binder LP, Simmons-Egolf WD, Burks SG, Bao Y, Taylor AG, Rodriguez J, Caldwell SH. Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial. J Hepatol. 2015 Jan;62(1):190-7. doi: 10.1016/j.jhep.2014.08.036. Epub 2014 Sep 6.
Results Reference
derived
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Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
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