Evaluation on the efficacy of docosahexaenoic acid for the treatment of nonalcoholic fatty liver disease in children

INTERVENTION: Product Name: DHA Product Code: NA Pharmaceutical Form: Chewable capsule, soft Current Sponsor code: A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ Pharmaceutical form of the placebo: Chewable capsule, soft Route of administration of the placebo: Oral use CONDITION: Nonalcoholic steatohepatitis ; MedDRA version: 14.1 Level: SOC Classification code 10027433 Term: Metabolism and nutrition disorders System Organ Class: 10027433 ‐ Metabolism and nutrition disorders Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] PRIMARY OUTCOME: Main Objective: To evaluate wether DHA suppementation decreases fatty liver content in children with NAFLD Primary end point(s): Reduction of hepatic fat content Secondary Objective: To evaluate wether DHA suppementation improves liver function as well as the insulinresistance Timepoint(s) of evaluation of this end point: six months SECONDARY OUTCOME: Secondary end point(s): improvement of liver and metabolic functions Timepoint(s) of evaluation of this end point: three and six months INCLUSION CRITERIA: Obese children and adolescents (BMI > 95th percentile), aged 6 to 18 years, with NAFLD Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range