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| Name | Class |
|---|---|
| Medical University of Bialystok | OTHER |
| Medical University of Silesia | OTHER |
| Pediatric Municipal Hospital of Rzeszow, Poland | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish oil | Experimental | Children will receive fish oil capsules according to age as described in the protocol |
|
| Placebo | Placebo Comparator | Sunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish Oil | Dietary Supplement | Fish oil given in supplementary dose |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Socha | Children's Memorial Health Institute, Warsaw, Poland | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25771388 | Derived | Janczyk W, Lebensztejn D, Wierzbicka-Rucinska A, Mazur A, Neuhoff-Murawska J, Matusik P, Socha P. Omega-3 Fatty acids therapy in children with nonalcoholic Fatty liver disease: a randomized controlled trial. J Pediatr. 2015 Jun;166(6):1358-63.e1-3. doi: 10.1016/j.jpeds.2015.01.056. Epub 2015 Mar 11. | |
| 23702094 | Derived |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| D006505 | Hepatitis |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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| 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 |
| Janczyk W, Socha P, Lebensztejn D, Wierzbicka A, Mazur A, Neuhoff-Murawska J, Matusik P. Omega-3 fatty acids for treatment of non-alcoholic fatty liver disease: design and rationale of randomized controlled trial. BMC Pediatr. 2013 May 23;13:85. doi: 10.1186/1471-2431-13-85. |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |