Abstract
BackgroundThere 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/designChildren 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.DiscussionTo 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 registrationAustralian New Zealand Clinical Trial Registry, ACTRN12615000144516. Registered on 16 February 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1428-8) contains supplementary material, which is available to authorized users.
Highlights
There is strong mechanistic evidence to suggest that vitamin D and omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFAs), docosahexaenoic acid (DHA), have the potential to significantly improve the symptoms of autism spectrum disorder (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
ASD is a life-long, disabling condition that is associated with deficits in social-communicative functioning, stereotypic behaviour and many behavioural and medical conditions including gastrointestinal symptoms [1, 2, 5,6,7]
Summary
ASD is a life-long, disabling condition that is associated with deficits in social-communicative functioning, stereotypic behaviour and many behavioural and medical conditions including gastrointestinal symptoms [1, 2, 5,6,7]. As far as we are aware, no other randomised, double-blind, placebo-controlled trial has investigated the effects of vitamin D on symptoms of ASD, and the few trials that have been conducted with n-3 LCPUFAs [38,39,40,41] have been limited by small samples sizes and short trial duration and have shown conflicting results The strength of this project lies in its design: part 1 has been designed to provide insight into the nutritional status of children with ASD in New Zealand. Our sample size and trial duration will ensure an adequate power to detect clinically and statistically significant results If this trial is able to identify nutritional interventions that can make even a small difference to the lives of children with ASD by reducing their symptoms, the benefits will be considerable in terms of social and emotional well-being and educational achievements. Abbreviations 25(OH)D, 25-hydroxyvitamin D; ABC, Aberrant Behaviour checklist; ASD, autism spectrum disorder; BPFAS, Behavioural Paediatrics Feeding Assessment Scale; CI, confidence interval; DHA, docosahexaenoic acid; DICE, Dietary Index of Children’s Eating; EPA, eicosapentaenoic acid; HNRU, Human Nutrition Research Unit; IU, international unit; n-3 LCPUFAs, omega-3 long chain polyunsaturated fatty acids; RBC, red blood cell; SPM, Sensory Processing Measures; SRS, Social Responsiveness Scale; WDHB, Waitemata District Health Board
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