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Could a simple nutrient boost baby brain development in all pregnancies?

NCT ID NCT07699393

Disease control Sponsor: Wayne State University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests whether giving choline supplements to pregnant women who do not drink alcohol can improve their babies' brain development and growth. Half the women receive a choline drink and half receive a placebo, and researchers measure infant memory, weight, and head size. The goal is to see if choline benefits all babies, not just those exposed to alcohol in the womb.

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 show that choline supplements during pregnancy broadly benefit fetal brain development and growth, not just in cases of alcohol exposure.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply widely. The supplement may have no measurable benefit in non-drinking women.

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 50 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

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 * Abstinence from alcohol since conception (by report) * 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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As listed by the trial registrant

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

Brain development Choline nutrition

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

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Contacts and locations

Locations

  • University of Cape Town

    RECRUITING

    Cape Town, South Africa

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