Nutritional supplements for children with autism
Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder
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 |
| Enrollment | 88 (estimated) |
| Ages | 30 Months to 72 Months |
| Sex | All |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06911905 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2.5 to 6 years who have been diagnosed with autism spectrum disorder.
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.
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 performed: While there have been studies exploring nutritional interventions in autism, this specific combination of supplements is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.