2026 Volume 72 Issue 5 Pages 406-414
Nutritional supplementation has produced inconsistent effects on autistic symptoms, and the evidence base is largely derived from Western populations. This study evaluated the preliminary efficacy and tolerability of a region-adapted multinutrient intervention in Chinese children with autism spectrum disorder. In this 12-wk pilot, randomised, double-blind, placebo-controlled trial, 50 children were assigned to receive either the intervention or a placebo. The primary endpoint was the change in the Autism Behavior Checklist total score. Secondary outcomes included developmental functioning assessed using the Psychoeducational Profile, Third Edition; gastrointestinal symptoms assessed using the Gastrointestinal Severity Index; and sleep assessed with the Children’s Sleep Habits Questionnaire. Between-group differences were analysed using baseline-adjusted models. All participants completed follow-up, and no serious adverse events were reported. The change in the Autism Behavior Checklist total score did not differ between groups (p=0.44). Receptive language on the Psychoeducational Profile, Third Edition improved more in the intervention group (difference in change=2.38; 95% confidence interval, 0.19–4.57; p=0.03). Other subscales showed mixed findings, including problem behaviour favouring control. Regarding tolerability, while abdominal pain improved in the intervention group (p=0.01), reports of night waking (p=0.01) and looser stools (p=0.05) increased. The prespecified primary endpoint was not met. Exploratory findings suggested a signal in receptive language, alongside tolerability trade-offs. These results require confirmation in adequately powered trials with refined endpoint selection and structured safety monitoring.
