Non-alcoholic Fatty Liver Disease
Conditions
Keywords
fatty liver, hepatitis, insulin resistance, unsaturated fatty acids, NAFLD, children
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.
Interventions
DIETARY_SUPPLEMENTFish Oil
Fish oil given in supplementary dose
Sponsors
Medical University of Bialystok
Medical University of Silesia
Pediatric Municipal Hospital of Rzeszow, Poland
Piotr Socha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 19 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Caloric intake including fat intake and sucrose intake | 6 months | 'Fish oil' group will be compared to 'placebo' group |
Outcome results
None listed