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Vitamin cocktail shows promise for autism symptoms in small trial

NCT ID NCT06911905

Symptom relief Sponsor: Fei Li Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a mix of vitamins and supplements could ease autism symptoms in 88 children aged 2.5 to 6 years. Half received the supplements plus behavioral therapy, the other half only behavioral therapy. After three months, researchers measured changes in social skills and overall improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nutritional supplements (vitamins B1, B2, folic acid, mecobalamin, D3, choline, and coenzyme Q10)
What this could lead to
If it works, this could point toward a simple, safe way to boost social skills in children with autism when added to behavioral therapy.
What could go wrong
This is a small Phase 2 trial with only 88 children, so results may not apply to everyone. Supplements may not improve symptoms beyond standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

88 people

The number who actually took part.

Started

Apr 2025

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 72 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder

Contacts and locations

Locations

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.