Autism Spectrum Disorder
Conditions
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.
Interventions
DIETARY_SUPPLEMENTNutritional 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.
BEHAVIORALTreatment as usual (TAU)
Participants will undergo treatment as usual, such as behavioral interventions
Sponsors
Fei Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Months to 72 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Responsiveness Scale, Second Edition (SRS-2) | From enrollment to the end of treatment at 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impressions Scale (CGI) | From enrollment to the end of treatment at 3 months | Clinical Global Impressions Scale (CGI) is a scale used to assess the severity of the illness and the global improvement of the participants under intervention.The Clinical Global Impression - Severity scale (CGI-S) is a clinician rated 7-point measure of overall severity. Scores range from 1 (Normal, not at all ill) through 4 (Moderately ill) to 7 (Among the most extremely ill patients). The Clinical Global Impression - Improvement scale (CGI-I) is the companion measure that evaluates the change in the patient's symptoms relative to baseline. Scores range from 1 (Very much improved) through 4 (No Change) to 7 (Very much worse). |
| Childhood Autism Rating Scale (CARS) | From enrollment to the end of treatment at 3 months | CARS is a behavior-rating scale used to assess the presence and severity of the symptoms associated autism spectrum disorder. The scores of the CARS rate from 15 to 60, and higher scores indicate more severe symptoms. The changes in the CARS scores from baseline to 3 months after the treatment will be analyzed to assess the impact of the intervention on participants with autism spectrum disorder |
| Aberrant Behavior Checklist (ABC) | From enrollment to the end of treatment at 3 months | Aberrant Behavior Checklist (ABC) is a 58-item instrument used to measure behavior problems across five sub-scales: hyperactivity, irritability, social withdrawal, stereotypic behavior and inappropriate speech. Each item rates behavior severity on a 4 point scale from 0 (Not at all a problem) to 3 (The problem is severe in degree). A higher score indicates more frequent aberrant behaviors.Changes of the total scores and scores of subscales from baseline to 3 month after treatment will be analyzed. |
| Chinese Communicative Development Inventory (CCDI) | From enrollment to the end of treatment at 3 months | Chinese Communicative Development Inventory (CCDI) is a questionnaire used to measures the language abilities. Higher scores suggest better language level. The changes in the CCDI between baseline and 3 month after treatment will be analyzed. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORFei Li, MD, PhD
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed