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Autism Spectrum DisorderPhase 2NCT06911905

Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder

A Phase 2 study testing Nutritional supplements and Treatment as usual (TAU) in people with Autism Spectrum Disorder, run by Fei Li at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 72 months
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Nutritional supplements and Treatment as usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteChina
Study dates
1 Apr 2025to 24 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 72 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

Other trials in China

About this study

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.

Read the 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.

Being tested
Nutritional supplements, Treatment as usual (TAU)
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional supplementsDietary supplement

    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.

  • Treatment as usual (TAU)Behavioural

    Participants will undergo treatment as usual, such as behavioral interventions

Study groups in NCT06911905
Study groupRoleWhat they receive
Nutritional supplements plus treatment as usual (TAU)ExperimentalParticipants in experimental group with received nutritional supplements, along with treatments as usual (i.e. behavioral interventions)
Receives: Dietary Supplement: Nutritional supplements; Behavioral: Treatment as usual (TAU)
Treatment as usual (TAU)OtherParticipants in the control group will undergo treatments as usual, such as behavioral interventions
Receives: Behavioral: Treatment as usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Social Responsiveness Scale, Second Edition (SRS-2)

    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.

    Measured: From enrollment to the end of treatment at 3 months

Secondary outcomes (4)

  1. Clinical Global Impressions Scale (CGI)

    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).

    Measured: From enrollment to the end of treatment at 3 months

  2. Childhood Autism Rating Scale (CARS)

    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

    Measured: From enrollment to the end of treatment at 3 months

  3. Aberrant Behavior Checklist (ABC)

    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.

    Measured: From enrollment to the end of treatment at 3 months

  4. Chinese Communicative Development Inventory (CCDI)

    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.

    Measured: From enrollment to the end of treatment at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study start1 Apr 2025
  3. Primary completion21 Mar 2026
  4. Study completion24 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06911905
Sponsor's protocol ID
XHEC-C-2024-086-2
Status last verified
Mar 2026
First submitted
28 Mar 2025
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The Study Protocol, Statistical Analysis Plan, Informed Consent Form, and other relevant documents will be available under reasonable and ethically approved request to the corresponding authors.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nutritional supplements and Treatment as usual (TAU) in people with Autism Spectrum Disorder, run by Fei Li at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Responsiveness Scale, Second Edition (SRS-2) (time frame: From enrollment to the end of treatment at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06911905.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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