The effects of purified n-3 fatty acids on serum biomarkers and cardiovascular risk markers in a randomized placebo controlled trial in patients with non alcoholic fatty liver disease - Treatment of non alcoholic fatty liver disease with n-3 fatty acids

Southampton University Hospitals NHS Trust0 个研究点目标入组 103 人开始时间: 2009年8月21日最近更新: 2019年2月28日

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•1. Steatohepatitis diagnosed on normal clinical grounds including in most cases liver biopsy and assessed by Kleiner scoring system to assess severity, with no known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B & C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).
•2. Steatosis diagnosed by ultrasound, CT or magnetic resonance imaging who also have either diabetes and/or features of the metabolic syndrome, and without evidence of known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B & C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).
•Liver biopsy or liver scan will be within 3 years of recruitment to the study.
•Age: men & women >18 years. Alcohol consumption <35 units / week for women <50 units / week for men) .
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Decompensated acute or chronic liver disease, or harmful drinking (>35u/week in women >50 u /week in men). Pregnancy. Lactating women. Hypersensitivity to Omacor, soya or any of the excipients.

发起方

Southampton University Hospitals NHS Trust