Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder

Last updated: April 13, 2025
Sponsor: Fei Li
Overall Status: Active - Recruiting

Phase

2

Condition

Autism

Asperger's Disorder

Williams Syndrome

Treatment

Nutritional supplements

Treatment as usual (TAU)

Clinical Study ID

NCT06911905
XHEC-C-2024-086-2
  • Ages 30-72
  • All Genders

Study 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

Inclusion Criteria:

  • Children aged between 2.5 and 6 years old

  • Meeting the ASD diagnostic criteria of the Diagnostic and Statistical Manual ofMental Disorders, Fifth Edition (DSM-5)

  • Meeting the ASD diagnostic criteria of the Diagnostic Observational Scale forAutism, Second Edition (ADOS-2）

  • CARS total score ≥ 30

  • Obtaining informed consent from the legal guardian

Exclusion

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

Study Design

Total Participants: 88
Treatment Group(s): 2
Primary Treatment: Nutritional supplements
Phase: 2
Study Start date:
April 01, 2025
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200092
    China

    Active - Recruiting

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