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Can a Nutrient-Packed supplement boost baby brain development and prevent early birth?

NCT ID NCT05949190

Disease control Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special food supplement with added omega-3s and choline can help undernourished pregnant women carry their babies longer and improve their babies' brain development. It also tests a simple talk therapy program to reduce depression during and after pregnancy. About 1,660 women in Sierra Leone are taking part.

What this could mean

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

Active substance
Maternal Ready-to-Use Supplementary Food with DHA/EPA/choline, azithromycin, albendazole, sulfadoxine pyrimethamine, cognitive behavioral therapy, insecticide-treated mosquito net
What this could lead to
If successful, this could show that adding specific nutrients to a supplement can prolong pregnancy and improve infant brain development, and that a simple therapy can reduce depression in pregnant women.
What could go wrong
This is a large trial, but results may not apply to other populations. The supplements and therapies are generally safe, but individual responses may vary.

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

1,660 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Oct 2026

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

13 years and older

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: In order to be eligible to participate in the M-RUSF+ vs. M-RUSF element of the study, an individual must meet all of the following criteria: 1. Provision of signed (or thumb-printed) and dated informed consent form 1a. Women who are ≥ 18 years of age or married will be allowed to consent for themselves 1b. Women who are \< 18 years of age and unmarried must provide assent and a parent or guardian must provide consent 2. Stated willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic 3. ≥ 13 years of age 4. Pregnant 5. Mid-upper arm circumference ≤ 23 cm or body-mass index \< 18.5 In order to be eligible to participate in the CBT vs. no CBT element of the study (factorial design with the above), an individual must be enrolled in the M-RUSF+ vs. M-RUSF study and meet the following criteria: 1. Provision of signed (or thumb-printed) and dated informed consent form 1a. Women who are ≥ 18 years of age or married will be allowed to consent for themselves 1b. Women who are \< 18 years of age and unmarried must assent and a parent or guardian consent must provide consent 2. Stated willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic 3. Patient Health Questionnaire-9 score ≥ 9 Exclusion Criteria: 1. Participation in a concomitant supplementary feeding program 2. Known allergy to components of intervention or control study food or medications 3. Known gestational diabetes 4. Hypertension 5. Severe anemia, or other condition requiring immediate hospitalization

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Conditions

The condition(s) this trial relates to.

nutritional deficiency disease postpartum depression Premature Birth

As listed by the trial registrant

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

Antepartum depression Child development Malnutrition in pregnancy Postpartum depression Preterm birth

Contacts and locations

Locations

  • Bandajuma

    Bandajuma, Southern Province, Sierra Leone

  • Bendu Malen

    Bendu, Southern Province, Sierra Leone

  • Blama Massaquoi

    Blama Massaquoi, Southern Province, Sierra Leone

  • Futa Peje

    Futa Peje, Southern Province, Sierra Leone

  • Gbondapi

    Gbondapi, Southern Province, Sierra Leone

  • Nyandehun Malen

    Nyandehun, Southern Province, Sierra Leone

  • Potoru

    Potoru, Southern Province, Sierra Leone

  • Pujehun Static

    Pujehun, Southern Province, Sierra Leone

  • Sahn Malen

    Sahn, Southern Province, Sierra Leone

  • Zimmi

    Zimmi, Southern Province, Sierra Leone

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