Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-31 @ 10:36 PM
Study NCT ID:
NCT06911905
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder
Sponsor:
Fei Li
Organization:
Study Overview
Official Title:
Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: