Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children

Study Overview
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Brief Summary
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The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.

Detailed Description
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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.

Official Title
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Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children - a Randomized, Double Blind, Placebo Controlled, Multicenter Study

Conditions
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Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Dietary Supplement: Fish Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 6-19 overweight or obesity ALT activity over 130% of upper limit norm hyperechogenicity of the liver on ultrasound Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil<br>Children will receive fish oil capsules according to age as described in the protocol | Dietary Supplement: Fish Oil<br>* Fish oil given in supplementary dose<br>|
| Placebo Comparator: Placebo<br>Sunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules | Dietary Supplement: Fish Oil<br>* Fish oil given in supplementary dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normalization of liver imaging on ultrasound | 'Fish oil' group will be compared to 'placebo' group | after 6 months of therapy | 
| ALT and AST activity | 'Fish oil' group will be compared to 'placebo' group | 6 months | 
| Insulin resistance markers as Homa-IR | 'Fish oil' group will be compared to 'placebo' group | 6 months | 
| Fat and lean body mass measurements | 'Fish oil' group will be compared to 'placebo' group | 6 months | 
| Caloric intake including fat intake and sucrose intake | 'Fish oil' group will be compared to 'placebo' group | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatty liver, hepatitis, insulin resistance, unsaturated fatty acids, NAFLD, children