Clinical trial NCT06911905: Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder
Official title: Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 88
Sex: ALL
Minimum age (years): 30
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 randomly assigned to either the experimental group or the control group.

Participants in the experimental group will receive the combination of nutritional supplements, including Vitamin B1, Vitamin B2, folic acid, Mecobalamin, Vitamin D3, Choline, and Coenzyme Q10, along with the behavioral interventions, for a period of three months. Participants in the control group will only undergo behavioral interventions.

during the intervention period, the clinical symptoms, metabolomics of bio-specimens, and potential adverse effects will be closely monitored.

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

Primary outcomes:
measure: Social Responsiveness Scale, Second Edition (SRS-2)
timeFrame: From enrollment to the end of treatment at 3 months
Secondary outcomes:
measure: Clinical Global Impressions Scale (CGI)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Childhood Autism Rating Scale (CARS)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Aberrant Behavior Checklist (ABC)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Chinese Communicative Development Inventory (CCDI)
timeFrame: From enrollment to the end of treatment at 3 months
Other outcomes:
measure: Metabolomics tests
timeFrame: From enrollment to the end of treatment at 3 months
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Fei Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: