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.
dc.citation.volume | 17 | |
dc.contributor.author | Mazahery H | |
dc.contributor.author | Conlon C | |
dc.contributor.author | Beck KL | |
dc.contributor.author | Kruger MC | |
dc.contributor.author | Stonehouse W | |
dc.contributor.author | Camargo CA | |
dc.contributor.author | Meyer BJ | |
dc.contributor.author | Tsang B | |
dc.contributor.author | Mugridge O | |
dc.contributor.author | von Hurst PR | |
dc.date.available | 2016-06-23 | |
dc.date.available | 2016-06-02 | |
dc.date.issued | 23/06/2016 | |
dc.description.abstract | BACKGROUND: 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-status | Published | |
dc.identifier | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000378990700001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=c5bb3b2499afac691c2e3c1a83ef6fef | |
dc.identifier | ARTN 295 | |
dc.identifier.citation | TRIALS, 2016, 17 | |
dc.identifier.doi | 10.1186/s13063-016-1428-8 | |
dc.identifier.eissn | 1745-6215 | |
dc.identifier.elements-id | 268121 | |
dc.identifier.harvested | Massey_Dark | |
dc.identifier.uri | https://hdl.handle.net/10179/10613 | |
dc.relation.isPartOf | TRIALS | |
dc.subject | Autism | |
dc.subject | ASD | |
dc.subject | Vitamin D | |
dc.subject | Omega-3 fatty acids | |
dc.subject | Supplements | |
dc.subject.anzsrc | 1102 Cardiorespiratory Medicine and Haematology | |
dc.subject.anzsrc | 1103 Clinical Sciences | |
dc.title | 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. | |
dc.type | Journal article | |
pubs.notes | Not 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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