Nutritional supplements for children with autism
Official title: Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder
Run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · NCT06911905 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if adding nutritional supplements to behavioral therapy can help young children with autism feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 30 Months to 72 Months |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06911905 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 2.5 to 6 years who have been diagnosed with autism spectrum disorder.
✕Probably not a fit
Patients with neurological diseases, congenital diseases, metabolic disorders, or those currently participating in other clinical trials may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the efficacy of nutritional supplements in alleviating symptoms of autism spectrum disorder (ASD) in children aged 2.5 to 6 years. Participants will be randomly assigned to receive either a combination of nutritional supplements and behavioral interventions or behavioral interventions alone for three months. The study will monitor clinical symptoms, metabolomics of bio-specimens, and any potential adverse effects during the intervention period. The goal is to determine if the addition of nutritional supplements enhances the effectiveness of behavioral therapy in treating ASD.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic approach to improve symptoms in children with autism spectrum disorder.
How similar studies have gone: While there have been studies exploring nutritional interventions in autism, this specific combination of supplements is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged between 2.5 and 6 years old * Meeting the ASD diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Meeting the ASD diagnostic criteria of the Diagnostic Observational Scale for Autism, Second Edition (ADOS-2） * CARS total score ≥ 30 * Obtaining informed consent from the legal guardian Exclusion Criteria: * History of neurological diseases such as epilepsy * History of congenital diseases such as hearing, visual impairment * Diagnosed with metabolic disorders such as hypophosphatemic rickets * Diagnosed with genetic or chromosomal abnormalities * Brain structural abnormalities detected by MRI which required surgical intervention * Currently participating in other clinical trials * Received any new intervention within 8 weeks prior to enrollment
Where it's running
-
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China Recruiting
Study contacts
- Principal investigator: Fei Li, MD, PhD — Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study coordinator: Fei Li, MD, PhD
- Email: feili@shsmu.edu.cn
- Phone: +86-18930830950
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.