Region-Adapted Multi-Nutrient Supplementation in Chinese Children with Autism Spectrum Disorder: A 12-Week Pilot Randomised Controlled Trial

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.