NCT00845845终止2 期
Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH)
研究概览
简要总结
The current pilot study assesses the use of magnetic resonance imaging (MRI) to quantify hepatic steatosis. It will provide preliminary data regarding the use of omega-3 fatty acid supplementation (Lovaza) for the treatment of nonalcoholic steatohepatitis (NASH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females at least 18 years of age.
- •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:
- •Patient provides written informed consent.
排除标准
- •Alcohol use exceeding 10 to 29 grams per day during the past six months.
- •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.
研究组 & 干预措施
Omega-3-acid ethyl esters (Lovaza)
Active Comparator
Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
干预措施: Omega-3-acid ethyl esters (Lovaza) (Drug)
Placebo
Placebo Comparator
Participants receive daily placebo and dietary counseling for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH)
时间窗: 24 weeks
次要结局
- Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH)(24 weeks)
研究者
Scott Cotler, MD
Professor of Medicine
University of Illinois at Chicago
研究点 (1)
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