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A simple nutrient may shield Babies' brains from iron deficiency

NCT ID NCT06527391

Disease control Sponsor: University of Minnesota 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether giving choline, a nutrient found in foods like eggs, alongside standard iron treatment can protect memory and learning in infants with iron deficiency anemia. About 300 six-month-old babies in Uganda will receive either choline or a placebo daily for nine months, along with iron. The study measures memory, attention, and overall development at 15 months of age to see if choline helps reduce the brain damage often caused by early iron deficiency.

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 effective, adding choline to standard iron treatment could help prevent long-term learning and memory problems in millions of children with early iron deficiency.
What could go wrong
This is a mid-stage trial, and results may not confirm the benefit. Choline is generally safe, but its effect on brain development in this context is still unproven.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 300 people

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

Started

Aug 2025

Expected to finish

Sep 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

5 to 7 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: * Age 6 months +/- 28 days * Hb \< 11.0 g/dL * ZPP \> = 80 * T\<37.5°C * Malaria-negative based on Rapid Diagnostic Test (RDT) * Mother is HIV-negative. Exclusion Criteria: * Developmental disorder * Severe malnutrition (severe wasting or bipedal edema) * Known sickle cell disease * Neurologic disorder, brain injury, or other condition affecting brain development * Not currently breastfeeding * Birthweight \< 2000 g

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Conditions

The condition(s) this trial relates to.

anemia Iron Deficiencies iron deficiency anemia

As listed by the trial registrant

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

Anemia Pediatric iron deficiency

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 Minnesota

    RECRUITING

    Minneapolis, Minnesota, 555455, United States

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