MedTrace Logo

Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder

NCT06911905 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-04-23

No results posted yet for this 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

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.

BEHAVIORAL

Treatment as usual (TAU)

Participants will undergo treatment as usual, such as behavioral interventions

Sponsors & Collaborators

  • Fei Li

    lead OTHER

Principal Investigators

  • Fei Li, MD, PhD · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Months
Max Age
72 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-03-21
Completion
2026-03-24

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06911905 on ClinicalTrials.gov