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Could a vitamin help kids with autism? new trial tests folinic acid

NCT ID NCT07630506

Symptom relief Sponsor: KK Women's and Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether folinic acid, a form of vitamin B9, can improve autism symptoms in children aged 3 to 10. About 184 children will receive either folinic acid or a placebo for 12 weeks, then all can try the vitamin. The goal is to see if it reduces behavioral and communication challenges.

What this could mean

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

Active substance
folinic acid (a form of vitamin B9)
What this could lead to
If it works, this could point toward a safe, vitamin-based option to ease autism symptoms in children.
What could go wrong
This is an early Phase 2 trial with only 184 children, so results may not be conclusive. Folinic acid is generally safe but may not improve symptoms for everyone.

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

About 184 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

3 to 10 years

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 3 years 0 months to 10 years 11 months at the time of enrolment * Weight ≥ 10 kg and ≤ 30 kg at the time of enrolment * Confirmed diagnosis of Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, supported by standardized diagnostic assessments * Stable on regular behavioral interventions and any medications for at least 6 months prior to enrolment * At least one parent or legal guardian able to understand and complete study questionnaires in English * Written informed consent obtained from a parent or legal guardian Exclusion Criteria: * Known allergy or intolerance to folinic acid * Current or prior supplementation with folinic acid or other folate preparations (folic acid supplementation permitted) * Vitamin B12 (cobalamin) deficiency or pernicious anemia * Concurrent use of medications known to interfere with folate metabolism (e.g., methotrexate, trimethoprim, fluorouracil, capecitabine, glucarpidase) * Known genetic, metabolic, or chromosomal disorder, or structural brain abnormalities * History of epilepsy or seizures (except simple febrile seizures) or current use of antiepileptic or antipsychotic medication * Significant sensory (hearing or visual) or motor impairment * Participation in another interventional clinical trial for autism within the past 6 months * Unable or unwilling to comply with study visits and procedures

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • KK Women's and Children's Hospital

    RECRUITING

    Singapore, Singapore, Singapore

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