title: Omega-3 Fatty acids therapy in children with nonalcoholic Fatty liver disease: a randomized controlled trial.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of omega-3 fatty acid supplementation in children with nonalcoholic fatty liver disease (NAFLD).
  
  
  METHODS
  Overweight/obese children with NAFLD (n = 76; median age, 13 years; IQR, 11.1-15.2 years) were eligible to participate in the study. The diagnosis of NAFLD was based on elevated alanine aminotransferase (ALT) to ≥ 30% of the upper limit of normal (ULN) and liver hyperechogenicity on ultrasound. Patients were randomized to receive omega-3 fatty acids (docosahexaenoic acid and eicosapentaenoic acid, 450-1300 mg/day) or placebo (omega-6 sunflower oil). The primary outcome was the number of patients who demonstrated decreased ALT activity by ≥ 0.3 times the ULN. Secondary outcomes included alterations in liver function tests, liver hyperechogenicity, insulin resistance, and other metabolic markers after 6 months of intervention.
  
  
  RESULTS
  Out of 76 enrolled patients, 64 completed the trial and were analyzed. After 6 months, we found no significant differences between the omega-3 and placebo groups in the number of patients with decreased ALT by ≥ 0.3 times the ULN (24 vs 23) or in median (IQR) ALT activity (48.5 [31-62] U/L vs 39 [27-55] U/L), liver hyperechogenicity, insulin resistance, or serum lipid levels. However, patients in the omega-3 group had lower levels of aspartate aminotransferase (28 [25-36] U/L vs 39 [27-55] U/L; P = .04) and gamma-glutamyl transpeptidase (26 [17.5-36.5] U/L vs 35 [22-52] U/L; P = .04), and significantly higher levels of adiponectin.
  
  
  CONCLUSIONS
  Omega-3 fatty acid supplementation did not increase the number of patients with decreased ALT levels and it did not affect liver steatosis on ultrasound, but it improved aspartate aminotransferase and gamma-glutamyl transpeptidase levels in children with NAFLD compared with placebo.
  
  
  BACKGROUND
  Registered with ClinicalTrials.gov: NCT01547910.
authors.affiliation: Department of Gastroenterology, Hepatology and Nutrition Disorders, The Children's Memorial Health Institute, Warsaw, Poland.
authors.forename: Wojciech
authors.initials: W
authors.lastname: Janczyk
authors.affiliation: Department of Pediatrics, Gastroenterology, and Allergology, Medical University of Bialystok, Bialystok, Poland.
authors.forename: Dariusz
authors.initials: D
authors.lastname: Lebensztejn
authors.affiliation: Department of Biochemistry and Radioimmunology, The Children's Memorial Health Institute, Warsaw, Poland.
authors.forename: Aldona
authors.initials: A
authors.lastname: Wierzbicka-Rucińska
authors.affiliation: Medical Faculty, University of Rzeszow, Rzeszow, Poland.
authors.forename: Artur
authors.initials: A
authors.lastname: Mazur
authors.affiliation: Department of Gastroenterology, Hepatology and Nutrition Disorders, The Children's Memorial Health Institute, Warsaw, Poland.
authors.forename: Joanna
authors.initials: J
authors.lastname: Neuhoff-Murawska
authors.affiliation: Department of Pediatrics, Pediatric Endocrinology and Diabetes, Medical University of Silesia, Katowice, Poland.
authors.forename: Paweł
authors.initials: P
authors.lastname: Matusik
authors.affiliation: Department of Gastroenterology, Hepatology and Nutrition Disorders, The Children's Memorial Health Institute, Warsaw, Poland. Electronic address: p.socha@czd.pl.
authors.forename: Piotr
authors.initials: P
authors.lastname: Socha
mesh_terms: D000293:Adolescent; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D002648:Child; D019587:Dietary Supplements; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D065626:Non-alcoholic Fatty Liver Disease / Q000097:blood / Q000188:drug therapy*; D005723:gamma-Glutamyltransferase / Q000097:blood
chemical_list: D015525:Fatty Acids, Omega-3; D005723:gamma-Glutamyltransferase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase