title: Randomized controlled trial of vitamin D supplementation in children with autism spectrum disorder.
abstract: BACKGROUND
  Autism spectrum disorder (ASD) is a frequent developmental disorder characterized by pervasive deficits in social interaction, impairment in verbal and nonverbal communication, and stereotyped patterns of interests and activities. It has been previously reported that there is vitamin D deficiency in autistic children; however, there is a lack of randomized controlled trials of vitamin D supplementation in ASD children.
  
  
  METHODS
  This study is a double-blinded, randomized clinical trial (RCT) that was conducted on 109 children with ASD (85 boys and 24 girls; aged 3-10 years). The aim of this study was to assess the effects of vitamin D supplementation on the core symptoms of autism in children. ASD patients were randomized to receive vitamin D3 or placebo for 4 months. The serum levels of 25-hydroxycholecalciferol (25 (OH)D) were measured at the beginning and at the end of the study. The autism severity and social maturity of the children were assessed by the Childhood Autism Rating Scale (CARS), Aberrant Behavior Checklist (ABC), Social Responsiveness Scale (SRS), and the Autism Treatment Evaluation Checklist (ATEC).
  
  
  BACKGROUND
  UMIN-CTR Study Design: trial number: UMIN000020281.
  
  
  RESULTS
  Supplementation of vitamin D was well tolerated by the ASD children. The daily doses used in the therapy group was 300 IU vitamin D3/kg/day, not to exceed 5,000 IU/day. The autism symptoms of the children improved significantly, following 4-month vitamin D3 supplementation, but not in the placebo group. This study demonstrates the efficacy and tolerability of high doses of vitamin D3 in children with ASD.
  
  
  CONCLUSIONS
  This study is the first double-blinded RCT proving the efficacy of vitamin D3 in ASD patients. Depending on the parameters measured in the study, oral vitamin D supplementation may safely improve signs and symptoms of ASD and could be recommended for children with ASD. At this stage, this study is a single RCT with a small number of patients, and a great deal of additional wide-scale studies are needed to critically validate the efficacy of vitamin D in ASD.
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Assiut University, Assiut, Egypt.
authors.forename: Khaled
authors.identifier: http://orcid.org/0000-0002-8473-6116
authors.initials: K
authors.lastname: Saad
authors.affiliation: Department of Neuropsychiatry, Faculty of Medicine, Assiut University, Assiut, Egypt.
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Abdel-Rahman
authors.affiliation: Department of Neuropsychiatry, Faculty of Medicine, Assiut University, Assiut, Egypt.
authors.forename: Yasser M
authors.initials: YM
authors.lastname: Elserogy
authors.affiliation: Department of Psychiatry, College of Medicine, Almajmaah University, Riyadh, Saudi Arabia.
authors.forename: Abdulrahman A
authors.initials: AA
authors.lastname: Al-Atram
authors.affiliation: Department of Community Health Nursing, Assiut University, Assiut, Egypt.
authors.forename: Amira A
authors.initials: AA
authors.lastname: El-Houfey
authors.affiliation: Department of Clinical Pathology, Aswan University, Aswan, Egypt.
authors.forename: Hisham A-K
authors.initials: HA
authors.lastname: Othman
authors.affiliation: Council for Nutritional and Environmental Medicine, Mo i Rana, Norway.
authors.forename: Geir
authors.initials: G
authors.lastname: Bjørklund
authors.affiliation: Department of Pediatric Neurology and Neurorehabilitation, The First Hospital of Jilin University, Changchun, China.
authors.forename: Feiyong
authors.initials: F
authors.lastname: Jia
authors.affiliation: Department of Biosciences, College of Life and Environmental Sciences, University of Exeter, Exeter, UK.|Departamento de Zoología, Facultad de Ciencias Naturales y Oceanográficas, Universidad de Concepción, Concepción, Chile.
authors.forename: Mauricio A
authors.initials: MA
authors.lastname: Urbina
authors.affiliation: Department of Pediatrics, Qena Faculty of Medicine, South Valley University, Qena, Egypt.
authors.forename: Mohamed Gamil M
authors.initials: MGM
authors.lastname: Abo-Elela
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Assiut University, Assiut, Egypt.
authors.forename: Faisal-Alkhateeb
authors.initials: FA
authors.lastname: Ahmad
authors.affiliation: Department of Pediatrics, Qena Faculty of Medicine, South Valley University, Qena, Egypt.
authors.forename: Khaled A
authors.initials: KA
authors.lastname: Abd El-Baseer
authors.affiliation: Department of Pediatrics, Qena Faculty of Medicine, South Valley University, Qena, Egypt.
authors.forename: Ahmed E
authors.initials: AE
authors.lastname: Ahmed
authors.affiliation: Department of Pharmaceutics and Industrial Pharmacy, Alazhar University, Assiut, Egypt.
authors.forename: Ahmad M
authors.initials: AM
authors.lastname: Abdel-Salam
mesh_terms: D000067877:Autism Spectrum Disorder / Q000097:blood* / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D014807:Vitamin D / Q000097:blood* / Q000627:therapeutic use*
chemical_list: D014807:Vitamin D
keywords: Autism spectrum disorder; children; clinical trial; vitamin D