The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
76
Fish oil given in supplementary dose
Serum alanine transaminase level decrease min. 0.3 upper limit of normal
Number of patients in whom ALT decreased min. 0.,3 ULN in 'fish oil' group compared to 'placebo' group
Time frame: 6 months
normalization of liver imaging on ultrasound
'Fish oil' group will be compared to 'placebo' group
Time frame: after 6 months of therapy
ALT and AST activity
'Fish oil' group will be compared to 'placebo' group
Time frame: 6 months
Insulin resistance markers as Homa-IR
'Fish oil' group will be compared to 'placebo' group
Time frame: 6 months
Fat and lean body mass measurements
'Fish oil' group will be compared to 'placebo' group
Time frame: 6 months
Caloric intake including fat intake and sucrose intake
'Fish oil' group will be compared to 'placebo' group
Time frame: 6 months
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