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- 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
Mazahery, Hajar; Conlon, Cathryn; Beck, Kathryn L.; Kruger, Marlena C.; Stonehouse, Welma; Camargo Jr., Carlos A.; Meyer, Barbara J.; Tsang, Bobby; Mugridge, Owen; von Hurst, Pamela R.; Camargo, Carlos A Jr
- Abstract
<bold>Background: </bold>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.<bold>Methods/design: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>Australian New Zealand Clinical Trial Registry, ACTRN12615000144516 . Registered on 16 February 2015.
- Subjects
AUTISM spectrum disorders in children; OMEGA-3 fatty acids; DIETARY supplements; RANDOMIZED controlled trials; CHILD health services; DIAGNOSIS; COMPARATIVE studies; DRUGS; RESEARCH methodology; MEDICAL cooperation; RESEARCH protocols; HEALTH outcome assessment; PATIENT compliance; RESEARCH; STATISTICS; VITAMIN D; DATA analysis; EVALUATION research; BLIND experiment
- Publication
Trials, 2016, Vol 17, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-016-1428-8