Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 6
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Fei Li, MD, PhD
feili@shsmu.edu.cn
+86-18930830950
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 88
Treatments
Experimental: Nutritional supplements plus treatment as usual (TAU)
Participants in experimental group with received nutritional supplements, along with treatments as usual (i.e. behavioral interventions)
Other: Treatment as usual (TAU)
Participants in the control group will undergo treatments as usual, such as behavioral interventions
Related Therapeutic Areas
Sponsors
Leads: Fei Li

This content was sourced from clinicaltrials.gov