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Could a simple nutrient shield babies from Alcohol's harm in the womb?

NCT ID NCT04395196

Disease control Sponsor: Wayne State University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests whether giving choline supplements to pregnant women who drink heavily can reduce the negative effects of alcohol on their baby's growth and brain development. Choline is an essential nutrient that supports cell membranes and brain function. The trial compares daily choline supplements to a placebo in 288 pregnant women in South Africa, measuring the babies' memory, weight, and head circumference after birth.

What this could mean

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

Active substance
choline bitartrate
What this could lead to
If it works, this could offer a simple, low-cost way to protect babies from some of the lasting effects of alcohol exposure during pregnancy.
What could go wrong
This is a mid-stage trial, so results are not yet proven. The supplement may not work as well in all women, and high doses could cause side effects.

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 288 people

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

Started

Apr 2023

Expected to finish

May 2028

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

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age ≥18 yr * ≤20 wk gestation * Singleton pregnancy * Currently heavy drinking (average of ≥15 ml AA/day or binge drinking (≥4 standard drinks/occasion) on at least 1.5 occasions/month on average since becoming pregnant) * Current choline dietary intake \<1 g/day * Language fluency in English or Afrikaans Exclusion Criteria: * Use of methamphetamine or other illicit drugs other than marijuana during the past year * HIV positive * Pharmacologic treatment for a serious pre-existing medical condition (e.g., diabetes, hypertension, epilepsy, or cardiac problems) * Having another child enrolled in the trial from a previous pregnancy * Plans for mother or child to move away from the area prior to study completion

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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 Fetal alcohol syndrome

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

  • University of Cape Town Faculty of Health Sciences

    RECRUITING

    Cape Town, Western Cape, 7925, South Africa

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