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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Hajar Mazahery, Cathryn Conlon, Kathryn L. Beck, Marlena C. Kruger, Welma Stonehouse, Carlos A. Camargo Jr., Barbara J. Meyer, Bobby Tsang, Owen Mugridge, Pamela R. von Hurst

Published in: Trials | Issue 1/2016

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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, ACTRN12615000144​516. Registered on 16 February 2015.
Appendix
Available only for authorised users
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Metadata
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
Authors
Hajar Mazahery
Cathryn Conlon
Kathryn L. Beck
Marlena C. Kruger
Welma Stonehouse
Carlos A. Camargo Jr.
Barbara J. Meyer
Bobby Tsang
Owen Mugridge
Pamela R. von Hurst
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1428-8

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