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

NCT ID NCT07642661

Symptom relief Sponsor: Prof. Adi Aran 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether folinic acid (a form of vitamin B9) can reduce irritability and improve behavior in 150 children aged 3 to 6 with autism. Half will get folinic acid, half a placebo, for 9 weeks. Researchers will also check if it helps with communication, sleep, and gut symptoms. The goal is to see if this supplement is safe and effective for core autism symptoms.

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 (leucovorin)
What this could lead to
If it works, this could point toward a safe, well-tolerated supplement to ease irritability and behavioral symptoms in young children with autism.
What could go wrong
This is a small, early-phase trial (Phase 2) with only 150 kids over 9 weeks. Previous studies were mixed, and the placebo effect can be strong in behavioral trials. It may not show clear benefit.

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 150 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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

3 to 6 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 to 6 years. * Diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria. * ASD diagnosis confirmed by Autism Diagnostic Observation Schedule, Second Edition (ADOS-2). * ASD diagnosis made at least 6 months before screening. * Non-syndromic ASD, defined as ASD occurring in the absence of a known genetic syndrome, chromosomal abnormality, major congenital anomaly, or identifiable metabolic or neurological disorder. * CGI-S score ≥ 4. * ABC-I score ≥ 12. * SRS-2 total T-score ≥ 66. * Body weight between 11.45 kg and \<27 kg. Exclusion Criteria: * A seizure or a change in antiepileptic medication within 8 weeks prior to randomization. * Clinically significant abnormalities on physical examination or laboratory testing, including significant impairment of cardiac, hepatic, or renal function. * Treatment with folinic acid within 3 months prior to randomization. * Any change in pharmacological treatment, behavioral treatment, home environment, or school setting (other than school holidays) within 4 weeks prior to randomization, or planned changes during study participation. * Predicted inability or unwillingness to comply with study procedures. * Use of antifolate medications or other agents known to interfere with folate metabolism (e.g., methotrexate, trimethoprim).

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Conditions

The condition(s) this trial relates to.

autism 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

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, N/A = Not Applicable, 9103102, Israel

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