Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder

NCT06911905 | Completed Phase 2 DMC

• 1 other identifier: XHEC-C-2024-086-2
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Social Responsiveness Scale, Second Edition (SRS-2)

  Social Responsiveness Scale, Second Edition (SRS-2) is a scale used to evaluate the presence and severity of social impairment. The scores of the SRS-2 rate from 0 to 195, and higher scores indicate more severe symptoms. Changes of the SRS-2 scores from baseline to 3 month after treatment will be analyzed to assess the effect of the intervention on children with autism spectrum disorder.

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (4)

• Clinical Global Impressions Scale (CGI)

  From enrollment to the end of treatment at 3 months

• Childhood Autism Rating Scale (CARS)

  From enrollment to the end of treatment at 3 months

• Aberrant Behavior Checklist (ABC)

  From enrollment to the end of treatment at 3 months

• Chinese Communicative Development Inventory (CCDI)

  From enrollment to the end of treatment at 3 months

Other Outcomes (1)

• Metabolomics tests

  From enrollment to the end of treatment at 3 months

Study Arms (2)

Nutritional supplements plus treatment as usual (TAU)

EXPERIMENTAL

Participants in experimental group with received nutritional supplements, along with treatments as usual (i.e. behavioral interventions)

Dietary Supplement: Nutritional supplements; Behavioral: Treatment as usual (TAU)

Treatment as usual (TAU)

OTHER

Participants in the control group will undergo treatments as usual, such as behavioral interventions

Behavioral: Treatment as usual (TAU)

Interventions

Nutritional supplements DIETARY_SUPPLEMENT

The nutritional supplements, including Vitamin B1, Vitamin B2, folic acid, Mecobalamin, Vitamin D3, Choline, and Coenzyme Q10, will be administered for a period of three months.

Nutritional supplements plus treatment as usual (TAU)

Treatment as usual (TAU) BEHAVIORAL

Participants will undergo treatment as usual, such as behavioral interventions

Nutritional supplements plus treatment as usual (TAU); Treatment as usual (TAU)

Eligibility Criteria

• Age: 30 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fei Li: lead

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Dietary Supplements; Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Fei Li, MD, PhD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Doctoral Supervisor

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2025
• Primary Completion: March 21, 2026
• Study Completion: March 24, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)