Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder

NCT ID: NCT06911905

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-12-31

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nutritional supplements plus treatment as usual (TAU)

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

Group Type: EXPERIMENTAL

Nutritional supplements

Intervention Type: 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.

Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

Participants will undergo treatment as usual, such as behavioral interventions

Treatment as usual (TAU)

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

Group Type: OTHER

Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

Participants will undergo treatment as usual, such as behavioral interventions

Interventions

Nutritional supplements

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.

Intervention Type: DIETARY_SUPPLEMENT

Treatment as usual (TAU)

Participants will undergo treatment as usual, such as behavioral interventions

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Months
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fei Li

OTHER

Sponsor Role: lead

Responsible Party

Fei Li

Chief Physician, Doctoral Supervisor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fei Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fei Li, MD, PhD

Role: CONTACT

feili@shsmu.edu.cn

+86-18930830950

Facility Contacts

Fei Li, Doctor

Role: primary

feili@shsmu.edu.cn

18930830950

Other Identifiers

XHEC-C-2024-086-2

Identifier Type: -

Identifier Source: org_study_id