Vitamin D and omega-3 fatty acid supplements in children with autism spectrum disorder: a study protocol for a factorial randomised, double-blind, placebo-controlled trial.

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dc.citation.volume17
dc.contributor.authorMazahery H
dc.contributor.authorConlon C
dc.contributor.authorBeck KL
dc.contributor.authorKruger MC
dc.contributor.authorStonehouse W
dc.contributor.authorCamargo CA
dc.contributor.authorMeyer BJ
dc.contributor.authorTsang B
dc.contributor.authorMugridge O
dc.contributor.authorvon Hurst PR
dc.date.available2016-06-23
dc.date.available2016-06-02
dc.date.issued2016-06-23
dc.description.abstractBACKGROUND: There is strong mechanistic evidence to suggest that vitamin D and omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFAs), specifically docosahexaenoic acid (DHA), have the potential to significantly improve the symptoms of autism spectrum disorder (ASD). However, there are no trials that have measured the effect of both vitamin D and n-3 LCPUFA supplementation on autism severity symptoms. The objective of this 2 × 2 factorial trial is to investigate the effect of vitamin D, n-3 LCPUFAs or a combination of both on core symptoms of ASD. METHODS/DESIGN: Children with ASD living in New Zealand (n = 168 children) will be randomised to one of four treatments daily: vitamin D (2000 IU), n-3 LCPUFAs (722 mg DHA), vitamin D (2000 IU) + n-3 LCPUFAs (722 mg DHA) or placebo for 12 months. All researchers, participants and their caregivers will be blinded until the data analysis is completed, and randomisation of the active/placebo capsules and allocation will be fully concealed from all mentioned parties. The primary outcome measures are the change in social-communicative functioning, sensory processing issues and problem behaviours between baseline and 12 months. A secondary outcome measure is the effect on gastrointestinal symptoms. Baseline data will be used to assess and correct basic nutritional deficiencies prior to treatment allocation. For safety measures, serum 25-hydroxyvitamin D 25(OH)D and calcium will be monitored at baseline, 6 and 12 months, and weekly compliance and gastrointestinal symptom diaries will be completed by caregivers throughout the study period. DISCUSSION: To our knowledge there are no randomised controlled trials assessing the effects of both vitamin D and DHA supplementation on core symptoms of ASD. If it is shown that either vitamin D, DHA or both are effective, the trial would reveal a non-invasive approach to managing ASD symptoms. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry, ACTRN12615000144516 . Registered on 16 February 2015.
dc.description.publication-statusPublished
dc.identifierhttp://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000378990700001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=c5bb3b2499afac691c2e3c1a83ef6fef
dc.identifierARTN 295
dc.identifier.citationTRIALS, 2016, 17
dc.identifier.doi10.1186/s13063-016-1428-8
dc.identifier.eissn1745-6215
dc.identifier.elements-id268121
dc.identifier.harvestedMassey_Dark
dc.relation.isPartOfTRIALS
dc.rights© 2016 Mazahery et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
dc.subjectAutism
dc.subjectASD
dc.subjectVitamin D
dc.subjectOmega-3 fatty acids
dc.subjectSupplements
dc.subject.anzsrc1102 Cardiorespiratory Medicine and Haematology
dc.subject.anzsrc1103 Clinical Sciences
dc.titleVitamin D and omega-3 fatty acid supplements in children with autism spectrum disorder: a study protocol for a factorial randomised, double-blind, placebo-controlled trial.
dc.typeJournal article
pubs.notesNot known
pubs.organisational-group/Massey University
pubs.organisational-group/Massey University/College of Health
pubs.organisational-group/Massey University/College of Health/School of Health Science
pubs.organisational-group/Massey University/College of Health/School of Sport, Exercise and Nutrition
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