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Recruiting Phase 2 NCT06911905

Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder

Trial Parameters

Condition Autism Spectrum Disorder
Sponsor Fei Li
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 88
Sex ALL
Min Age 30 Months
Max Age 72 Months
Start Date 2025-04-01
Completion 2025-12-31
Interventions
Nutritional supplementsTreatment as usual (TAU)

Brief Summary

The goal of this clinical trial is to learn if nutritional supplements could alleviate the clinical symptoms in children with autism spectrum disorder. It will also learn about the safety of these nutritional supplements. Researchers will compare the combination of nutritional supplements and behavioral intervention, to behavioral intervention alone, to see if nutritional supplements work to treat autism. Participants will receive the combination of nutritional supplements and behavioral interventions or solely behavioral interventions for 3 months. And they will visit the clinic at the beginning of the trial (baseline) and after the 3-month intervention period for examinations.

Eligibility 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

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