NCT06911905CompletedPhase 2
Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 28 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 21 Mar 2026
- Lead sponsor
- Fei Li
- Diseases
- Autism
- NCT number
- NCT06911905
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 88
- From 1 Apr 2025 to the primary completion date, 21 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Brain structural abnormalities detected by MRI which required surgical intervention
- Received any new intervention within 8 weeks prior to enrollment
Other illness
- History of neurological diseases such as epilepsy
- History of congenital diseases such as hearing, visual impairment
- Diagnosed with metabolic disorders such as hypophosphatemic rickets
Other
- Diagnosed with genetic or chromosomal abnormalities
- Currently participating in other clinical trials
Who the study is looking for
- 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
Age in the registry: 30 months to 72 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.