A randomised controlled trial of vitamin D and omega-3 long chain polyunsaturated fatty acids in the treatment of irritability and hyperactivity among children with autism spectrum disorder

Mazahery, Hajar; Conlon, Cathryn A.; Beck, Kathryn; Mugridge, Owen; Kruger, Marlena C.; Stonehouse, Welma; Camargo, Carlos A.; Meyer, Barbara J.; Jones, Bronwyn; Hurst, Pamela von

doi:10.1016/j.jsbmb.2018.10.017

Cited by 65 publications

(97 citation statements)

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“…Finally, we identified 23 full text articles corresponding to 10 RCTs [40][41][42][43][44][45][46][47][48][49] through the search strategy for experimental studies (see also Additional file 2 and Fig. 1).…”

Section: Studies Retrieved Through the Search Strategy For Rctsmentioning

confidence: 99%

“…We retrieved 809 citations from database searching and 3 studies from unstructured web searching. We excluded 788 documents from title and abstract, and after excluding 15 full text articles for various reasons (see Additional file 2) we finally included 10 non-randomized studies reporting data on equity, acceptability or feasibility [9,[41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58] (see Fig. 1).…”

Section: Non-randomized Studies Retrieved Through the Search Strategymentioning

confidence: 99%

“…We found one article [50] and one thesis [51] reporting data about the cost of PUFAs in the world. To obtain data on the dosage in the population of interest we have used the data contained in the RCTs [40][41][42][43][44][45][46][47][48] (see Fig. 1).…”

Section: Resources Requiredmentioning

confidence: 99%

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Equity, acceptability and feasibility of using polyunsaturated fatty acids in children and adolescents with autism spectrum disorder: a rapid systematic review

D’Alò

Crescenzo

Morgano

et al. 2020

Health Qual Life Outcomes

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Introduction: Some recent randomized controlled trials (RCTs) assessed the efficacy and safety of polyunsaturated fatty acids (PUFAs) for the treatment of autism spectrum disorder (ASD). To optimally inform the Italian guideline for the management of ASD in children and adolescents, we reviewed the impact on equity, acceptability and feasibility for developing a pilot recommendation for PUFAs. Methods: We performed a rapid systematic review of observational and experimental studies on PUFAs for children and adolescents with ASD, extracting data on resources required, equity, acceptability, and feasibility of PUFAs. We followed the framework provided by the grading of recommendations assessment, development and evaluation (GRADE) methodology, and we assessed risk of bias and methodological quality of included studies. Results were synthesized both narratively and quantitatively to address clinically relevant questions on equity, acceptability, and feasibility. Results: We found 14 papers related to equity. PUFAs did not seem to impact equity importantly. We did not find variation in effectiveness across subgroups and in a base case scenario, the cost of a 12 weeks cycle of therapy with 1.155 g/day of PUFAs was €65.51 euro. The acceptability of PUFAs was evaluated in 17 studies, 9 of which were RCTs. PUFAs were widely used among children and adolescents with ASD (18 to 51%), and 50% of parents considered nutritional supplementation as useful. Difficulty in swallowing capsules and bad taste were identified as possible causes of poor compliance, but treatment adherence, when measured in included RCTs, was judged to be good to excellent. Discontinuation due to any cause for PUFAs could not differ from placebo (low certainty of evidence). The feasibility of using PUFAs was assessed in 12 studies. PUFAs were probably sustainable, and no particular critical issue emerged from the feasibility assessment. However, the evidence appeared scarce and indirect.

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Section: Studies Retrieved Through the Search Strategy For Rctsmentioning

confidence: 99%

Section: Non-randomized Studies Retrieved Through the Search Strategymentioning

confidence: 99%

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Equity, acceptability and feasibility of using polyunsaturated fatty acids in children and adolescents with autism spectrum disorder: a rapid systematic review

D’Alò

Crescenzo

Morgano

et al. 2020

Health Qual Life Outcomes

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“…This study was conducted as an exploratory analysis of the data from the Vitamin D and Omega-3 LCPUFA in Autism (VIDOMA) trial. A detailed description of the design of the VIDOMA trial and its main results have been published [43,49,50]. The protocol was registered with the Australian New Zealand Clinical Trial Registry, ACTRN12615000144516, and the ethical approval was granted by Health and Disability Ethics Committee, NZ, Reference NO.…”

Section: Study Design and Participantsmentioning

confidence: 99%

Inflammation (IL-1β) Modifies the Effect of Vitamin D and Omega-3 Long Chain Polyunsaturated Fatty Acids on Core Symptoms of Autism Spectrum Disorder—An Exploratory Pilot Study

et al. 2020

Self Cite

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Background: The role of vitamin D and omega-3 long chain polyunsaturated fatty acids (omega-3 LCPUFA) in improving core symptoms of autism spectrum disorder (ASD) in children has been investigated by a few randomised controlled trials and the results are mixed and inconclusive. The response to treatment with these nutrients is heterogenous and may be influenced by inflammatory state. As an exploratory analysis, we investigated whether inflammatory state would modulate the effect of these nutrients on core symptoms of ASD. Methods: Seventy-three New Zealand children with ASD (2.5-8.0 years) completed a 12-month randomised, double-blind, placebo-controlled trial of vitamin D (VID, 2000 IU/day), omega-3 LCPUFA; (OM, 722 mg/day docosahexaenoic acid), or both (VIDOM). Non-fasting baseline plasma interleukin-1β (IL-1β) was available for 67 children (VID = 15, OM = 21, VIDOM = 15, placebo = 16). Children were categorised as having undetectable/normal IL-1β (<3.2 pg/ml, n = 15) or elevated IL-1β (≥3.2 pg/mL, n = 52). The Social Responsiveness Scale (SRS) questionnaire was used to assess core symptoms of ASD (baseline, 12-month). Mixed model repeated measure analyses (including all children or only children with elevated IL-1β) were used. Results: We found evidence for an interaction between baseline IL-1β and treatment response for SRS-total, SRS-social communicative functioning, SRS-awareness and SRS-communication (all P interaction < 0.10). When all children were included in the analysis, two outcome comparisons (treatments vs. placebo) showed greater improvements: VID, no effect (all P > 0.10); OM and VIDOM (P = 0.01) for SRS-awareness. When only children with elevated IL-1β were included, five outcomes showed greater improvements: OM (P = 0.01) for SRS-total; OM (P = 0.03) for SRS-social communicative Nutrients 2020, 12, 661 2 of 17 functioning; VID (P = 0.01), OM (P = 0.003) and VIDOM (P = 0.01) for SRS-awareness. Conclusion: Inflammatory state may have modulated responses to vitamin D and omega-3 LCPUFA intervention in children with ASD, suggesting children with elevated inflammation may benefit more from daily vitamin D and omega-3 LCPUFA supplementation.

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“…Baseline serum vitamin D levels of both the experimental and control groups in the three studies included in this meta-analysis were recorded. We only selected the data on vitamin D group and placebo group, neglecting unrelated information such as that on omega-3 group and vitamin D ＋ omega-3 group, in the studies of Fang et al [52] and Mazahery et al [53,54]. Results showed that there were no significant differences in baseline serum vitamin D levels between the experimental and control groups in the three included studies (SMD = 0.3, 95% CI = −0.06 to 0.65; p = 0.1), and low heterogeneity was noted among the three studies (I 2 = 0%) ( Fig.…”

Section: Serum Vitamin D Levelsmentioning

confidence: 99%

Vitamin D Supplementation is Beneficial for Children with Autism Spectrum Disorder: A Meta-analysis

Song

Luo

Jiang

et al. 2020

Clin Psychopharmacol Neurosci

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Objective: We conducted a meta-analysis of randomized controlled trials to explore whether vitamin D supplementation is beneficial for symptom improvement in children with autism spectrum disorder. Methods: We systematically searched the PubMed database, EMBASE, Cochrane Library, Web of Science, Sino-Med, Wanfang Data, and China National Knowledge Infrastructure mainly up to September 2019. Using a fixed effects model, we calculated the standard mean difference with 95% confidence interval. Furthermore, we analyzed baseline serum 25-hydroxyvitamin D levels and outcome scores including the Social Responsiveness Scale and Child Autism Rating Scale scores after vitamin D supplementation. Results: There was no significant difference in baseline serum 25-hydroxyvitamin D levels among 203 children included from three studies in the meta-analysis. After vitamin D supplementation, the outcome scores in the experimental group were dramatically elevated compared with those in the control group (p = 0.03). Conclusion: Vitamin D supplementation improves the typical symptoms of autism spectrum disorder, as indicated by reduced Social Responsiveness Scale and Child Autism Rating Scale scores; thus, it is beneficial for children with autism spectrum disorder.

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A randomised controlled trial of vitamin D and omega-3 long chain polyunsaturated fatty acids in the treatment of irritability and hyperactivity among children with autism spectrum disorder

Cited by 65 publications

References 50 publications

Equity, acceptability and feasibility of using polyunsaturated fatty acids in children and adolescents with autism spectrum disorder: a rapid systematic review

Equity, acceptability and feasibility of using polyunsaturated fatty acids in children and adolescents with autism spectrum disorder: a rapid systematic review

Inflammation (IL-1β) Modifies the Effect of Vitamin D and Omega-3 Long Chain Polyunsaturated Fatty Acids on Core Symptoms of Autism Spectrum Disorder—An Exploratory Pilot Study

Vitamin D Supplementation is Beneficial for Children with Autism Spectrum Disorder: A Meta-analysis

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