NCT01277237已完成3 期
The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Liver appearance on ultrasound
研究概览
简要总结
There is preliminary evidence that Omega 3, a compound naturally found in fish oil, reduces the amount of fat stored in the liver and improves liver function. The purpose of this study is to see whether this observation is correct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •a diagnosis of non-alcoholic fatty liver disease
- •fatty infiltration on ultrasound
- •abnormal serum liver function tests.
排除标准
- •any other identified cause of chronic liver disease
- •the prescription of medication which would cause non-alcoholic fatty liver - disease (e.g. tamoxifen)
- •already taking supplementary fish oil
- •alcohol intake of >20g/day for women, >40g/ day for men
- •known allergy to fish oil
- •on anticoagulants (antiplatelets are permitted)
- •severe heart failure (NYHA class IV)
- •pregnancy/ lactation
- •age under 18 years.
研究组 & 干预措施
Omacor
Active Comparator
干预措施: Omacor (Drug)
Lactose tablet
Placebo Comparator
干预措施: lactose tablet (Drug)
结局指标
主要结局
Liver appearance on ultrasound
时间窗: 6 months
The primary endpoint is improvement in grading on ultrasound assessment at six months. Liver brightness and posterior attenuation on ultrasound has previously been shown to correlate significantly with fat scores on liver biopsy.
次要结局
- hepatocyte mitochondrial function(6 months)
- Liver function tests(6 months)
- Health-related Quality of Life(6 months)
研究者
研究点 (1)
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