Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder

Fei Li

Status and phase: Enrolling; Phase 2

Conditions: Autism Spectrum Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06911905

XHEC-C-2024-086-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 30 to 72 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Nutritional supplements plus treatment as usual (TAU)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Nutritional supplements

Behavioral: Treatment as usual (TAU)

Treatment as usual (TAU)

Other group

Description:

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

Treatment:

Behavioral: Treatment as usual (TAU)