Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children
- Conditions
- Non-alcoholic Fatty Liver Disease
- Interventions
- Dietary Supplement: Fish Oil
- Registration Number
- NCT01547910
- Lead Sponsor
- Piotr Socha
- Brief Summary
The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- age 6-19
- overweight or obesity
- ALT activity over 130% of upper limit norm
- hyperechogenicity of the liver on ultrasound
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fish oil Fish Oil Children will receive fish oil capsules according to age as described in the protocol Placebo Fish Oil Sunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules
- Primary Outcome Measures
Name Time Method Serum alanine transaminase level decrease min. 0.3 upper limit of normal 6 months Number of patients in whom ALT decreased min. 0.,3 ULN in 'fish oil' group compared to 'placebo' group
- Secondary Outcome Measures
Name Time Method Caloric intake including fat intake and sucrose intake 6 months 'Fish oil' group will be compared to 'placebo' group
Insulin resistance markers as Homa-IR 6 months 'Fish oil' group will be compared to 'placebo' group
Fat and lean body mass measurements 6 months 'Fish oil' group will be compared to 'placebo' group
normalization of liver imaging on ultrasound after 6 months of therapy 'Fish oil' group will be compared to 'placebo' group
ALT and AST activity 6 months 'Fish oil' group will be compared to 'placebo' group