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Could a common nutrient boost brain power in children exposed to alcohol before birth?

NCT ID NCT05108974

Disease control Sponsor: Jeff Wozniak 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study tests whether choline, a vitamin-like nutrient, can improve memory, thinking, and behavior in children aged 2.5 to 5 years with Fetal Alcohol Spectrum Disorders (FASD). Participants receive choline daily for either 3 or 6 months. Researchers measure changes in memory, intelligence, and executive function to see if choline helps offset the effects of prenatal alcohol exposure.

What this could mean

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

Active substance
choline (vitamin-like nutrient)
What this could lead to
If it works, choline could become a simple, safe supplement to help children with FASD improve memory and thinking skills.
What could go wrong
This is a small, early-stage trial. Choline may not improve cognitive outcomes, and results may not apply to all children with FASD.

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

62 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Jul 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

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: * Ages 2.5 years to 5 years old (\<6 years of age) at enrollment * Prenatal alcohol exposure * Available parent or legal guardian capable of giving informed consent for participation. Exclusion Criteria: * History of a neurological condition (ex. epilepsy, traumatic brain injury) * History of a medical condition known to affect brain function * Other neurodevelopmental disorder (ex. autism, Down syndrome) * History of very low birthweight (\<1500 grams)

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Conditions

The condition(s) this trial relates to.

fetal alcohol spectrum disorder fetal alcohol syndrome

As listed by the trial registrant

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

Fetal alcohol spectrum disorders

Contacts and locations

Locations

  • University of Minnesota

    Minneapolis, Minnesota, 55454, United States

More trials for these conditions

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