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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00681408 |
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 |
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Non-Alcoholic Steatohepatitis Fatty Liver |
Drug: Omega 3 Fish Oil supplements Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-Alcoholic Steatohepatitis (NASH) |
Estimated Enrollment: | 64 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Omega 3 recipient arm: Active Comparator |
Drug: Omega 3 Fish Oil supplements
Subjects in this arm will receive 3 grams daily Omega 3 fish oil supplements
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Placebo: Placebo Comparator
Placebo fish oil
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Drug: Placebo
Fish oil placebo pills
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Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Virginia | |
University of Virginia School of Medicine | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Stephen H Caldwell, MD 434-924-2626 shc5c@virginia.edu | |
Principal Investigator: Stephen H Caldwell, MD |
Principal Investigator: | Stephen H Caldwell, MD | University of Virginia |
Responsible Party: | University of Virginia Health System, Division of Gastroenterology ( Stephen H. Caldwell, MD ) |
Study ID Numbers: | R21 AT002901, IRB # 12442, GCRC: SHC003, Grant # 5R21AT2901-2 |
Study First Received: | May 19, 2008 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00681408 |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
Steatohepatitis NASH NAFLD omega 3 fatty acids Exercise conditioning |
Liver Diseases Non-alcoholic steatohepatitis (NASH) Digestive System Diseases Fatty Liver |