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

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Stephen Caldwell, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT00681408
First received: May 19, 2008
Last updated: May 27, 2015
Last verified: May 2015
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)

Resource links provided by NLM:


Further study details as provided by Stephen Caldwell, MD, University of Virginia:

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

Enrollment: 41
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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681408

Locations
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)
Investigators
Principal Investigator: Stephen H Caldwell, MD University of Virginia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen Caldwell, MD, Professor, Department of Gastroenterology, University of Virginia
ClinicalTrials.gov Identifier: NCT00681408     History of Changes
Other Study ID Numbers: 12442
R21AT002901 ( U.S. NIH Grant/Contract )
IRB # 12442
GCRC: SHC003
Grant # 5R21AT2901-2
Study First Received: May 19, 2008
Last Updated: May 27, 2015

Keywords provided by Stephen Caldwell, MD, University of Virginia:
Steatohepatitis
NASH
NAFLD
omega 3 fatty acids
Exercise conditioning

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 26, 2017