Status:
RECRUITING
Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder
Lead Sponsor:
Fei Li
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
30-72 years
Phase:
PHASE2
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 nut...
Detailed Description
This is an open-label clinical trial aimed at investigating whether nutritional supplements could alleviate the clinical symptoms in children with autism spectrum disorder. Participants will be random...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06911905
Start Date
April 1 2025
End Date
December 31 2025
Last Update
April 16 2025
Active Locations (1)
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1
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092