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ω-3 and ω-6 Fatty Acid Supplementation May Reduce Autism Symptoms Based on Parent Report in Preterm Toddlers
Sarah A Keim1,2,3, Barbara Gracious4,5,6, Kelly M Boone1
1Centers for Biobehavioral Health, Innovation in Pediatric Practice, and Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH.
Insights
This pilot study suggests that Omega-3-6-9 fatty acid supplementation may reduce autism spectrum disorder (ASD) symptoms in very preterm infants. Further research is needed to confirm these promising findings for children born preterm.
Area of Science:
- Neonatal Research
- Nutritional Science
- Developmental Pediatrics
Background:
- Children born preterm face an elevated risk for autism spectrum disorder (ASD).
- Omega-3 (n-3) and Omega-6 (n-6) fatty acids, including gamma-linolenic acid (GLA), show potential benefits for preterm infants with early ASD signs.
- Previous studies indicate docosahexaenoic acid (DHA) supports cognitive development and n-3/GLA combinations may improve ADHD symptoms.
Purpose of the Study:
- To assess the feasibility of a larger clinical trial for very preterm toddlers with ASD symptoms.
- To explore the impact of specific fatty acid supplementation on parent-reported ASD symptoms and related behaviors.
Main Methods:
- A 90-day, randomized, double-blind, placebo-controlled pilot trial involving 31 children born at or before 29 weeks gestation (18-38 months old).
- Participants received either daily Omega-3-6-9 Junior (containing EPA, DHA, GLA) or a placebo (canola oil).
- Intent-to-treat analysis using mixed-effects regression models analyzed parent-reported outcomes.
Main Results:
- Twenty-eight children completed the trial with complete outcome data.
- Children receiving Omega-3-6-9 Junior showed a statistically significant greater reduction in ASD symptoms compared to placebo (difference: -2.1 points; 95% CI: -4.1 to -0.2).
- The observed effect was confined to one subscale of the assessment, with no significant effects on other outcome measures.
Conclusions:
- The pilot trial successfully confirmed feasibility, with adequate enrollment and full participation without safety concerns.
- Clinically significant improvements in ASD symptoms were observed in the supplemented group, though effects were limited to a specific subscale.
- A full-scale trial is recommended due to the lack of effective treatments for this vulnerable population; registered at ClinicalTrials.gov (NCT01683565).
Background:
Children born preterm are at increased risk of autism spectrum disorder (ASD). n-3 (ω-3) Combined with n-6 (ω-6) fatty acids including γ-linolenic acid (GLA) may benefit children born preterm showing early signs of ASD. Previous trials have reported that docosahexaenoic acid (DHA) promotes cognitive development in preterm neonates and n-3 fatty acids combined with GLA improve attention-deficit-hyperactivity disorder.
Objectives:
The objectives of the pilot Preemie Tots Trial were 1) to confirm the feasibility of a full-scale trial in toddlers born very preterm and exhibiting ASD symptoms and 2) to explore the effects of supplementation on parent-reported ASD symptoms and related behaviors.
Methods:
This was a 90-d randomized, fully blinded, placebo-controlled trial in 31 children 18-38 mo of age who were born at ≤29 wk of gestation. One group was assigned to daily Omega-3-6-9 Junior (Nordic Naturals, Inc.) treatment (including 338 mg eicosapentaenoic acid, 225 mg DHA, and 83 mg GLA), and the other group received canola oil (124 mg palmitic acid, 39 mg stearic acid, 513 mg linoleic acid, 225 mg α-linolenic acid, and 1346 mg oleic acid). Mixed-effects regression analyses followed intent-to-treat analysis and explored effects on parent-reported ASD symptoms and related behaviors.
Results:
Of 31 children randomly assigned, 28 had complete outcome data. After accounting for baseline scores, those assigned to treatment exhibited a greater reduction in ASD symptoms per the Brief Infant Toddler Social Emotional Assessment ASD scale than did those assigned to placebo (difference in change = - 2.1 points; 95% CI: - 4.1, - 0.2 points; standardized effect size = - 0.71). No other outcome measure reflected a similar magnitude or a significant effect.
Conclusions:
This pilot trial confirmed adequate numbers of children enrolled and participated fully in the trial. No safety concerns were noted. It also found clinically-significant improvements in ASD symptoms for children randomly assigned to receive Omega-3-6-9 Junior, but effects were confined to one subscale. A future full-scale trial is warranted given the lack of effective treatments for this population. This trial was registered at www.clinicaltrials.gov as NCT01683565.
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