Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)
NCT ID: NCT00845845
Last Updated: 2013-07-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2006-03-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Omega-3-acid ethyl esters (Lovaza)
Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
Omega-3-acid ethyl esters (Lovaza)
4 milligrams daily omega-3-acid ethyl esters (Lovaza) with dietary counseling for 24 weeks.
Placebo
Participants receive daily placebo and dietary counseling for 24 weeks
Placebo
Daily placebo with dietary counseling for 24 weeks.
Interventions
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Omega-3-acid ethyl esters (Lovaza)
4 milligrams daily omega-3-acid ethyl esters (Lovaza) with dietary counseling for 24 weeks.
Placebo
Daily placebo with dietary counseling for 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of nonalcoholic steatohepatitis (NASH) on a liver biopsy performed within six months of entry to this study.
* Laboratory parameters indicative of decompensated liver disease including:
* bilirubin less than 2 milligrams/decilitre (mg/dl).
* stable albumin within normal limits.
* prothrombin time less than 3 seconds prolonged.
* Serum creatinine less than 1.5 times the upper limit of normal.
* Diabetic patients must be stable on oral medication for diabetes or have had less than a 10 percent change in their insulin dose over the past two months.
* Thyroid stimulating hormone (TSH) or Free Thyroxine Index (FTI) within the normal range.
* Hepatitis C antibody negative.
* Hepatitis B Surface Antigen (HBsAg) seronegative.
* Antinuclear antibody (ANA) less than 1:320.
* Patient provides written informed consent.
Exclusion Criteria
* Evidence of a cause of liver disease other than nonalcoholic steatohepatitis (NASH) on liver biopsy including: viral hepatitis, alcoholic liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, or recent hepatoxic drug exposure.
* Patients with cirrhosis.
* Use of medications commonly associated with nonalcoholic steatohepatitis (NASH) including: glucocorticoids, estrogens, tamoxifen, methotrexate, nifedipine, diltiazem, chloroquine, isoniazid, or amiodarone within the past six months.
* Use of non-steroidal antiinflammatory drugs, fibrates (fenofibrate or gemfibrozil) or warfarin within one month of entering the study.
* Uncontrolled diabetes, defined as a glycated hemoglobin (A1C) level greater than 8%.
* Patients with insulin-dependent diabetes.
* History of jejunal-ileal bypass or extensive small bowel resection.
* Substance abuse including, but not limited to, alcohol or intravenous and inhaled drugs within the past six months.
* Use of chemotherapy within six months of enrollment.
* Patients taking metformin.
* Thyroid abnormality in which normal thyroid function cannot be maintained by medication.
* Pregnancy, females who are breastfeeding.
* Solid organ transplant recipient.
* History of a medical condition, which could interfere with participation in and completion of the protocol.
* Use of oral supplements of Vitamin E within one month of enrollment.
18 Years
ALL
No
Sponsors
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University of Illinois at Chicago
OTHER
Responsible Party
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Scott Cotler, MD
Professor of Medicine
Principal Investigators
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Scott Cotler, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Illinois Chicago
Locations
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The University of Illinois Chicago
Chicago, Illinois, United States
Countries
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References
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Reid AE. Nonalcoholic steatohepatitis. Gastroenterology. 2001 Sep;121(3):710-23. doi: 10.1053/gast.2001.27126.
Bacon BR, Farahvash MJ, Janney CG, Neuschwander-Tetri BA. Nonalcoholic steatohepatitis: an expanded clinical entity. Gastroenterology. 1994 Oct;107(4):1103-9. doi: 10.1016/0016-5085(94)90235-6.
Mofrad P, Contos MJ, Haque M, Sargeant C, Fisher RA, Luketic VA, Sterling RK, Shiffman ML, Stravitz RT, Sanyal AJ. Clinical and histologic spectrum of nonalcoholic fatty liver disease associated with normal ALT values. Hepatology. 2003 Jun;37(6):1286-92. doi: 10.1053/jhep.2003.50229.
Caldwell SH, Oelsner DH, Iezzoni JC, Hespenheide EE, Battle EH, Driscoll CJ. Cryptogenic cirrhosis: clinical characterization and risk factors for underlying disease. Hepatology. 1999 Mar;29(3):664-9. doi: 10.1002/hep.510290347.
Marrero JA, Fontana RJ, Su GL, Conjeevaram HS, Emick DM, Lok AS. NAFLD may be a common underlying liver disease in patients with hepatocellular carcinoma in the United States. Hepatology. 2002 Dec;36(6):1349-54. doi: 10.1053/jhep.2002.36939.
Neuschwander-Tetri BA, Caldwell SH. Nonalcoholic steatohepatitis: summary of an AASLD Single Topic Conference. Hepatology. 2003 May;37(5):1202-19. doi: 10.1053/jhep.2003.50193.
Chalasani N, Gorski JC, Asghar MS, Asghar A, Foresman B, Hall SD, Crabb DW. Hepatic cytochrome P450 2E1 activity in nondiabetic patients with nonalcoholic steatohepatitis. Hepatology. 2003 Mar;37(3):544-50. doi: 10.1053/jhep.2003.50095.
Li Z, Yang S, Lin H, Huang J, Watkins PA, Moser AB, Desimone C, Song XY, Diehl AM. Probiotics and antibodies to TNF inhibit inflammatory activity and improve nonalcoholic fatty liver disease. Hepatology. 2003 Feb;37(2):343-50. doi: 10.1053/jhep.2003.50048.
Listenberger LL, Han X, Lewis SE, Cases S, Farese RV Jr, Ory DS, Schaffer JE. Triglyceride accumulation protects against fatty acid-induced lipotoxicity. Proc Natl Acad Sci U S A. 2003 Mar 18;100(6):3077-82. doi: 10.1073/pnas.0630588100. Epub 2003 Mar 10.
Saxena NK, Ikeda K, Rockey DC, Friedman SL, Anania FA. Leptin in hepatic fibrosis: evidence for increased collagen production in stellate cells and lean littermates of ob/ob mice. Hepatology. 2002 Apr;35(4):762-71. doi: 10.1053/jhep.2002.32029.
Lavine JE. Vitamin E treatment of nonalcoholic steatohepatitis in children: a pilot study. J Pediatr. 2000 Jun;136(6):734-8.
Neuschwander-Tetri BA, Brunt EM, Wehmeier KR, Sponseller CA, Hampton K, Bacon BR. Interim results of a pilot study demonstrating the early effects of the PPAR-gamma ligand rosiglitazone on insulin sensitivity, aminotransferases, hepatic steatosis and body weight in patients with non-alcoholic steatohepatitis. J Hepatol. 2003 Apr;38(4):434-40. doi: 10.1016/s0168-8278(03)00027-8.
Marchesini G, Brizi M, Bianchi G, Tomassetti S, Zoli M, Melchionda N. Metformin in non-alcoholic steatohepatitis. Lancet. 2001 Sep 15;358(9285):893-4. doi: 10.1016/s0140-6736(01)06042-1.
Kudo N, Kawashima Y. Fish oil-feeding prevents perfluorooctanoic acid-induced fatty liver in mice. Toxicol Appl Pharmacol. 1997 Aug;145(2):285-93. doi: 10.1006/taap.1997.8186.
Neschen S, Moore I, Regittnig W, Yu CL, Wang Y, Pypaert M, Petersen KF, Shulman GI. Contrasting effects of fish oil and safflower oil on hepatic peroxisomal and tissue lipid content. Am J Physiol Endocrinol Metab. 2002 Feb;282(2):E395-401. doi: 10.1152/ajpendo.00414.2001.
Kris-Etherton PM, Harris WS, Appel LJ; Nutrition Committee. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Arterioscler Thromb Vasc Biol. 2003 Feb 1;23(2):e20-30. doi: 10.1161/01.atv.0000038493.65177.94. No abstract available.
Saito M, Kubo K. Relationship between tissue lipid peroxidation and peroxidizability index after alpha-linolenic, eicosapentaenoic, or docosahexaenoic acid intake in rats. Br J Nutr. 2003 Jan;89(1):19-28. doi: 10.1079/BJN2002731.
Meagher EA, Barry OP, Burke A, Lucey MR, Lawson JA, Rokach J, FitzGerald GA. Alcohol-induced generation of lipid peroxidation products in humans. J Clin Invest. 1999 Sep;104(6):805-13. doi: 10.1172/JCI5584.
Saad MF, Anderson RL, Laws A, Watanabe RM, Kades WW, Chen YD, Sands RE, Pei D, Savage PJ, Bergman RN. A comparison between the minimal model and the glucose clamp in the assessment of insulin sensitivity across the spectrum of glucose tolerance. Insulin Resistance Atherosclerosis Study. Diabetes. 1994 Sep;43(9):1114-21. doi: 10.2337/diab.43.9.1114.
Brunt EM, Janney CG, Di Bisceglie AM, Neuschwander-Tetri BA, Bacon BR. Nonalcoholic steatohepatitis: a proposal for grading and staging the histological lesions. Am J Gastroenterol. 1999 Sep;94(9):2467-74. doi: 10.1111/j.1572-0241.1999.01377.x.
Other Identifiers
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2003-0601
Identifier Type: -
Identifier Source: org_study_id
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