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Toddler formula trial aims to improve iron levels

NCT ID NCT07324135

Disease control Sponsor: Nutricia Research 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Updated 2 times

Summary

This study tests whether a young child formula can improve iron status in children aged 1 to 3 years. About 466 healthy or mildly anemic kids will receive either the test formula or a control product for a set period. Researchers will measure blood ferritin levels and daily iron intake to see if the formula makes a difference.

What this could mean

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

Active substance
young child formula (nutritional product)
What this could lead to
If successful, this could show that a specific formula helps maintain healthy iron levels in toddlers, potentially reducing mild iron deficiency.
What could go wrong
This is an early-stage nutritional study, not a treatment for severe anemia. Results may not apply to all children, and the effect on iron status may be small.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 466 people

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

Started

Mar 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 36 months

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: * Children aged 1 to 3 years * Healthy children (as per investigator clinical judgement and non-anaemic as confirmed by Hb levels) or meeting the criteria for mild anaemia based on Hb levels * Children familiar with drinking milk products (in combination with breastfeeding or not) for at least 3 weeks prior to screening. * Written informed consent provided by parent(s) / legally acceptable representative(s) aged ≥18 years at screening Exclusion Criteria: * Low Hb meeting the criteria for moderate or severe anaemia * Use of iron and/or fibre supplementation within 3 months prior to screening * Any infection within 2 weeks prior to screening * Any other medical condition with known high CRP (\>5 mg/L) / high AGP (\>1 g/L) value within 2 weeks prior to screening * The use of medication that is likely to interfere with iron metabolism) within 2 weeks prior to screening * The use of medication to treat iron deficiency or anaemia within 3 months prior to screening * Any developmental delays that could impact feeding behaviour or growth, or any other condition that is likely to influence nutritional status or growth. * Disorders requiring a special diet. * Any other iron metabolism and related disorders * Children with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances.

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Conditions

The condition(s) this trial relates to.

anemia

As listed by the trial registrant

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

Iron status

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

  • Faculty of Medicine University of Indonesia

    RECRUITING

    Jakarta, Indonesia

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