title: Omega-3 fatty acids for treatment of non-alcoholic fatty liver disease: design and rationale of randomized controlled trial.
abstract: BACKGROUND
  Non-alcoholic fatty liver disease (NAFLD) is a liver manifestation of metabolic syndrome since obesity and insulin resistance are the main pathogenic contributors for both conditions. NAFLD carries increased risk of atherosclerosis and cardiovascular diseases. There is an urgent need to find effective and safe therapy for children and adults with NAFLD. Data from research and clinical studies suggest that omega-3 fatty acids may be beneficial in metabolic syndrome-related conditions and can reduce the risk of cardiovascular disease.
  
  
  METHODS
  We are conducting a randomized, multicenter, double-blind, placebo-controlled trial of treatment with omega-3 fatty acids in children with NAFLD. Patients are randomized to receive either omega-3 fatty acids containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) or placebo for 24 weeks. The dose of omega-3 (DHA+ EPA) ranges from 450 to 1300 mg daily. Low calorie diet and increased physical activity are advised and monitored using validated questionnaires. The primary outcome of the trial is the number of patients who decreased ALT activity by ≥ 0,3 of upper limit of normal. The main secondary outcomes are improvement in the laboratory liver tests, liver steatosis on ultrasound, markers of insulin resistance and difference in fat/lean body mass composition after 6 months of intervention.
  
  
  CONCLUSIONS
  Potential efficacy of omega-3 fatty acids in the treatment of NAFLD will provide needed rationale for use of this safe diet supplement together with weight reduction therapy in the growing population of children with NAFLD.
  
  
  BACKGROUND
  NCT01547910.
authors.affiliation: Department Gastroenterology, Hepatology and Eating Disorders, Children's Memorial Health Institute, Warsaw, Poland. w.janczyk@czd.pl
authors.forename: Wojciech
authors.initials: W
authors.lastname: Janczyk
authors.forename: Piotr
authors.initials: P
authors.lastname: Socha
authors.forename: Dariusz
authors.initials: D
authors.lastname: Lebensztejn
authors.forename: Aldona
authors.initials: A
authors.lastname: Wierzbicka
authors.forename: Artur
authors.initials: A
authors.lastname: Mazur
authors.forename: Joanna
authors.initials: J
authors.lastname: Neuhoff-Murawska
authors.forename: Pawel
authors.initials: P
authors.lastname: Matusik
mesh_terms: D000293:Adolescent; D002648:Child; D002985:Clinical Protocols; D015930:Diet Records; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000627:therapeutic use*; D004311:Double-Blind Method; D015118:Eicosapentaenoic Acid / Q000627:therapeutic use*; D005234:Fatty Liver / Q000178:diet therapy*; D005500:Follow-Up Studies; D006801:Humans; D065626:Non-alcoholic Fatty Liver Disease; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid