title: Docosahexanoic Acid Plus Vitamin D Treatment Improves Features of NAFLD in Children with Serum Vitamin D Deficiency: Results from a Single Centre Trial.
abstract: BACKGROUND
  There are no licensed treatments for non alcoholic fatty liver disease (NAFLD) in adults or children. In NAFLD, several studies have shown a benefit of omega-3 fatty acid treatment on lipid profile, insulin-sensitivity and hepatic steatosis and it has also been suggested that Vitamin D treatment has potential antifibrotic properties in liver disease.
  
  
  METHODS
  To date, however, there are no studies that have tested the combination of Docosahexanoic acid (DHA) and vitamin D treatment which may benefit the whole spectrum of disease in NAFLD. Our aim therefore, was to test the effect of daily DHA (500 mg) plus vitamin D (800 IU) treatment, in obese children with biopsy-proven NAFLD and vitamin D deficiency, in a randomized, double-blind placebo-controlled trial.
  
  
  METHODS
  The 41/43 patients completed the study (18-treatment, 23-placebo). At 12 months: i) the main outcome was liver histology improvement, defined by NAS; ii) the secondary outcome was amelioration of metabolic parameters.
  
  
  RESULTS
  DHA plus vitamin D treatment reduced the NAFLD Activity Score (NAS), in the treatment group (5.4 v1.92; p<0.001 for baseline versus end of study). There was no change in fibrosis score, but a reduction of the activation of hepatic stellate cells (HSC) and fibrillar collagen content was noted (3.51±1.66 v. 1.59±1.37; p = 0.003) in treatment group. Moreover, the triglycerides (174.5 vs. 102.15 mg/dl), ALT (40.25 vs. 24.5 UI/l) and HOMA-IR (4.59 vs. 3.42) were all decreased with treatment.
  
  
  CONCLUSIONS
  DHA plus vitamin D treatment improved insulin-resistance, lipid profile, ALT and NAS. There was also decreased HSC activation and collagen content with treatment.
authors.affiliation: Hepato-Metabolic Department, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Della Corte
authors.affiliation: Department of Movement, Human and Health Sciences, Division of Health Sciences, University of Rome "Foro Italico"- Rome, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Carpino
authors.affiliation: Histopathology Unit, "Bambino Gesù" Children's Hospital, IRCCS- Rome, Italy.
authors.forename: Rita
authors.initials: R
authors.lastname: De Vito
authors.affiliation: Liver Research Unit, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
authors.forename: Cristiano
authors.initials: C
authors.lastname: De Stefanis
authors.affiliation: Liver Research Unit, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Alisi
authors.affiliation: Endocrinology and Diabetes Unit, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Cianfarani
authors.affiliation: Department of Anatomical, Histological, Forensic Medicine and Orthopedics Sciences, Sapienza University of Rome-Rome, Italy.
authors.forename: Diletta
authors.initials: D
authors.lastname: Overi
authors.affiliation: Hepato-Metabolic Department, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Mosca
authors.affiliation: Department of Cellular Biotechnology and Hematology, Sapienza University Hospital Umberto I, Rome, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Stronati
authors.affiliation: Department of Pediatrics, Pediatric Gastroenterology and Liver Unit, Sapienza University Hospital Umberto I, Rome, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cucchiara
authors.affiliation: Medical Directorate, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Raponi
authors.affiliation: Department of Anatomical, Histological, Forensic Medicine and Orthopedics Sciences, Sapienza University of Rome-Rome, Italy.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Gaudio
authors.affiliation: Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton-, Southampton, United Kingdom.|NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, United Kingdom.
authors.forename: Christopher D
authors.initials: CD
authors.lastname: Byrne
authors.affiliation: Hepato-Metabolic Department, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.|Liver Research Unit, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
authors.forename: Valerio
authors.initials: V
authors.lastname: Nobili
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004281:Docosahexaenoic Acids / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008099:Liver / Q000473:pathology*; D008297:Male; D065626:Non-alcoholic Fatty Liver Disease / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D014807:Vitamin D / Q000627:therapeutic use*; D014808:Vitamin D Deficiency / Q000150:complications / Q000188:drug therapy* / Q000473:pathology
chemical_list: D014807:Vitamin D; D004281:Docosahexaenoic Acids