Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children - a Randomized, Double Blind, Placebo Controlled, Multicenter Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 主要终点
- Serum alanine transaminase level decrease min. 0.3 upper limit of normal
研究概览
简要总结
The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.
详细描述
76 children or adolescents aged 6-19 with NAFLD will be included in the study. Diagnosis of NAFLD is set by increased alanine transaminase and features of liver steatosis on ultrasound. Patients will be randomized to receive either fish oil (EPA/DHA, 400-1200mg) or placebo (sunflower oil) for 6 months. All children will be advised to reduce weight (dietetic intervention + increased physical activity). Laboratory tests, liver ultrasound, anthropometric analysis will be performed at the start, after 3 months and 6 months.
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
- 6 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •overweight or obesity
- •ALT activity over 130% of upper limit norm
- •hyperechogenicity of the liver on ultrasound
排除标准
- •HCV, HBV infection
- •cholestasis
- •chronic/acute liver failure
- •alpha-1-antitrypsin deficiency
- •Wilson disease
- •type 2 diabetes mellitus
- •beta-oxidation defects
- •alcohol consumption
- •history of parenteral nutrition
- •use of drugs
研究组 & 干预措施
Placebo
Sunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules
干预措施: Fish Oil (Dietary Supplement)
Fish oil
Children will receive fish oil capsules according to age as described in the protocol
干预措施: Fish Oil (Dietary Supplement)
结局指标
主要结局
Serum alanine transaminase level decrease min. 0.3 upper limit of normal
时间窗: 6 months
Number of patients in whom ALT decreased min. 0.,3 ULN in 'fish oil' group compared to 'placebo' group
次要结局
- normalization of liver imaging on ultrasound(after 6 months of therapy)
- ALT and AST activity(6 months)
- Caloric intake including fat intake and sucrose intake(6 months)
- Insulin resistance markers as Homa-IR(6 months)
- Fat and lean body mass measurements(6 months)
研究者
Piotr Socha
Professor PhD MD, Principal Investigator
Children's Memorial Health Institute, Poland