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Can a better diet during malnutrition recovery rewire a Child's brain?

NCT ID NCT05629624

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study looks at whether specially designed nutritional supplements can improve thinking skills and emotional control in young children in Bangladesh who have moderate malnutrition. About 300 children aged 1 to 3 years receive either standard or enhanced nutritional supplements along with a psychosocial stimulation program. Researchers measure changes in brain activity and development using tests and brain imaging.

What this could mean

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

Active substance
special nutritional supplements (E-RUSF and E-SQLNS) plus psychosocial stimulation
What this could lead to
If successful, this could show that targeted nutrition during early childhood recovery from malnutrition can improve brain development and emotional regulation.
What could go wrong
This is a small pilot study, so results may not apply broadly. The supplements may not outperform standard feeds, and long-term benefits remain uncertain.

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

297 people

The number who actually took part.

Started

Feb 2022

Finished

Jan 2025

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

12 to 39 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: Inclusion criteria for malnourished (MAM) children at 1 and 3 years of age: All of the following criteria must be met for a subject to be eligible to participate in the study * Mother willing to sign consent form * Child age 12-15 months or 36-39 months of age * WHZ \<-2 and ≥-3 z-score, and/or MUAC \<12.5 and ≥11.5 cm and free from any acute illness * Mother agrees to feed their children a study diet at home. * Mother willing to bring the child to the clinic for assessment (morbidity, nutrition history, adherence to treatment, anthropometry and advice to mother on parenting) and clinical examination. * Mother will agree to provide her biological samples * Mother willing to have a child undergo biological sample collection and neuropsychological assessment at baseline (1-year-old) and at ages 2 years and 3 years at the clinic. * Family has no plan to move from the study area in the next three years. Inclusion criteria for Control group with normal health (normal Z score): * Mother willing to sign consent form * Child age 12-15 months * WHZ score \> -1 and free from any acute illness * Mother willing to bring the child to the clinic for assessment (morbidity, nutrition history, adherence to treatment, anthropometry and advice to mother on parenting) and clinical examination. * Mother will agree to provide her biological samples (see below). * Mother willing to have a child undergo biological sample collection and neuropsychological assessment at baseline at 1 year old and again at 2 years and 3 years at the clinic. * Family has no plan to move from the study area in the next two years. Exclusion Criteria: Exclusion criteria for malnourished (MAM) children: Meeting any of the following criteria will exclude a subject from study participation * Mother who is not willing to sign a consent form. * Congenital anomaly. * Mother who is not willing to feed the rehabilitation feed or the small quantity supplement to her child. * Family will not stay 3 years in the study area. Exclusion criteria for Control group with normal health (normal Z score): Meeting any of the following criteria will exclude a subject from study participation - * Mother who is not willing to sign a consent form. * Child age \>15 months or \< 12m. * Mother who is not willing to feed the rehabilitation feed or the small quantity supplement to her child. * Family will not stay 3 years in the study area. * Any congenital anomaly.

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Conditions

The condition(s) this trial relates to.

Child Nutrition Disorders Emotional Regulation Malnutrition nutritional deficiency disease

As listed by the trial registrant

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

Contacts and locations

Locations

  • International Centre for Diarrheal Disease Research

    Dhaka, Bangladesh

More trials for these conditions

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