Randomized controlled trial of vitamin D supplementation in children with autism spectrum disorder / Khaled SAAD in Journal of Child Psychology and Psychiatry, 59-1 (January 2018)  

Public ISBD [article]  inJournal of Child Psychology and Psychiatry > 59-1 (January 2018) . - p.20-29 Titre : Randomized controlled trial of vitamin D supplementation in children with autism spectrum disorder Type de document : Texte imprimé et/ou numérique Auteurs : Khaled SAAD, Auteur ; Ahmed A. ABDEL-RAHMAN, Auteur ; Yasser M. ELSEROGY, Auteur ; Abdulrahman A. AL-ATRAM, Auteur ; Amira A. EL-HOUFEY, Auteur ; Hisham A. K. OTHMAN, Auteur ; Geir BJØRKLUND, Auteur ; Feiyong JIA, Auteur ; Mauricio A. URBINA, Auteur ; Mohamed Gamil M. ABO-ELELA, Auteur ; Faisal-Alkhateeb AHMAD, Auteur ; Khaled A. ABD EL-BASEER, Auteur ; Ahmed E. AHMED, Auteur ; Ahmad M. ABDEL-SALAM, Auteur Article en page(s) : p.20-29 Langues : Anglais (eng) Mots-clés : Autism spectrum disorder  vitamin D  children  clinical trial Index. décimale : PER Périodiques Résumé : 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). Trial registration number: 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. En ligne : http://dx.doi.org/10.1111/jcpp.12652 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=327 [article] Randomized controlled trial of vitamin D supplementation in children with autism spectrum disorder [Texte imprimé et/ou numérique] / Khaled SAAD, Auteur ; Ahmed A. ABDEL-RAHMAN, Auteur ; Yasser M. ELSEROGY, Auteur ; Abdulrahman A. AL-ATRAM, Auteur ; Amira A. EL-HOUFEY, Auteur ; Hisham A. K. OTHMAN, Auteur ; Geir BJØRKLUND, Auteur ; Feiyong JIA, Auteur ; Mauricio A. URBINA, Auteur ; Mohamed Gamil M. ABO-ELELA, Auteur ; Faisal-Alkhateeb AHMAD, Auteur ; Khaled A. ABD EL-BASEER, Auteur ; Ahmed E. AHMED, Auteur ; Ahmad M. ABDEL-SALAM, Auteur . - p.20-29. Langues : Anglais (eng) in Journal of Child Psychology and Psychiatry > 59-1 (January 2018) . - p.20-29 Mots-clés : Autism spectrum disorder  vitamin D  children  clinical trial Index. décimale : PER Périodiques Résumé : 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). Trial registration number: 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. En ligne : http://dx.doi.org/10.1111/jcpp.12652 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=327

Retraction: Randomized controlled trial of vitamin D supplementation in children with autism spectrum disorder / K. SAAD in Journal of Child Psychology and Psychiatry, 60-6 (June 2019)  

Public ISBD [article]  inJournal of Child Psychology and Psychiatry > 60-6 (June 2019) . - p.711 Titre : Retraction: Randomized controlled trial of vitamin D supplementation in children with autism spectrum disorder Type de document : Texte imprimé et/ou numérique Auteurs : K. SAAD, Auteur ; Ahmed A. ABDEL-RAHMAN, Auteur ; Y. ELSEROGY, Auteur ; Abdulrahman A. AL-ATRAM, Auteur ; A. EL-HOUFEY, Auteur ; H. OTHMAN, Auteur ; G. BJORKLUND, Auteur ; F. JIA, Auteur ; M. URBINA, Auteur ; Mohamed Gamil M. ABO-ELELA, Auteur ; F. AHMAD, Auteur ; Khaled A. ABD EL-BASEER, Auteur ; A. AHMED, Auteur ; Ahmad M. ABDEL-SALAM, Auteur Article en page(s) : p.711 Langues : Anglais (eng) Index. décimale : PER Périodiques Résumé : The above article, published in print in the Jan 2018 issue of the Journal of Child Psychology & Psychiatry and online in Wiley Online Library (wileyonlinelibrary.com), has been retracted by the JCPP Editor-in-Chief, Edmund Sonuga-Barke, and John Wiley & Sons. Following a series of communications from readers highlighting concerns about the paper (now published on the journal website), the journal editors requested that the authors send them the raw data from the trial. In response the authors informed the editors that; (i) the electronic data base had been lost following a computer outage and (ii) that they could send only 95 out of 120 hard-copy participant data sheets as one site had closed and was no longer contactable. The substantial data loss in and of itself posed a serious difficulty in verifying the correctness of the data presented in the paper. The JCPP then analysed the data from the 95 cases itself. A number of significant discrepancies emerged between the re-analysis and the findings reported in the paper both in terms of means and standard deviations of key outcome variables across the trial. These involved very substantial differences that we judged to be extremely unlikely to have arisen due to variations in composition of the original and re-analysed samples. We also discovered previously unidentified/reported problems with missing data and recording irregularities regarding changes in treatment regimen and subject identifiers. As a result of these issues the Editors no longer have confidence in the findings reported in the original paper. Based on all these matters combined and following published guidance from the Committee on Publishing Ethics (COPE) and Wiley's Best Practice Guidelines on Publishing Ethics, we have decided that the only course of action available to us is to retract the paper. En ligne : http://dx.doi.org/10.1111/jcpp.13076 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=397 [article] Retraction: Randomized controlled trial of vitamin D supplementation in children with autism spectrum disorder [Texte imprimé et/ou numérique] / K. SAAD, Auteur ; Ahmed A. ABDEL-RAHMAN, Auteur ; Y. ELSEROGY, Auteur ; Abdulrahman A. AL-ATRAM, Auteur ; A. EL-HOUFEY, Auteur ; H. OTHMAN, Auteur ; G. BJORKLUND, Auteur ; F. JIA, Auteur ; M. URBINA, Auteur ; Mohamed Gamil M. ABO-ELELA, Auteur ; F. AHMAD, Auteur ; Khaled A. ABD EL-BASEER, Auteur ; A. AHMED, Auteur ; Ahmad M. ABDEL-SALAM, Auteur . - p.711. Langues : Anglais (eng) in Journal of Child Psychology and Psychiatry > 60-6 (June 2019) . - p.711 Index. décimale : PER Périodiques Résumé : The above article, published in print in the Jan 2018 issue of the Journal of Child Psychology & Psychiatry and online in Wiley Online Library (wileyonlinelibrary.com), has been retracted by the JCPP Editor-in-Chief, Edmund Sonuga-Barke, and John Wiley & Sons. Following a series of communications from readers highlighting concerns about the paper (now published on the journal website), the journal editors requested that the authors send them the raw data from the trial. In response the authors informed the editors that; (i) the electronic data base had been lost following a computer outage and (ii) that they could send only 95 out of 120 hard-copy participant data sheets as one site had closed and was no longer contactable. The substantial data loss in and of itself posed a serious difficulty in verifying the correctness of the data presented in the paper. The JCPP then analysed the data from the 95 cases itself. A number of significant discrepancies emerged between the re-analysis and the findings reported in the paper both in terms of means and standard deviations of key outcome variables across the trial. These involved very substantial differences that we judged to be extremely unlikely to have arisen due to variations in composition of the original and re-analysed samples. We also discovered previously unidentified/reported problems with missing data and recording irregularities regarding changes in treatment regimen and subject identifiers. As a result of these issues the Editors no longer have confidence in the findings reported in the original paper. Based on all these matters combined and following published guidance from the Committee on Publishing Ethics (COPE) and Wiley's Best Practice Guidelines on Publishing Ethics, we have decided that the only course of action available to us is to retract the paper. En ligne : http://dx.doi.org/10.1111/jcpp.13076 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=397

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