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Smart supplement strategy could save babies in ethiopia

NCT ID NCT06125860

Prevention Sponsor: Harvard School of Public Health (HSPH) 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study in Addis Ababa, Ethiopia, tests whether giving protein supplements only to pregnant women who are undernourished can prevent problems like low birth weight and stillbirth. Over 6,700 pregnant women are randomly assigned to receive supplements either universally or only if they are underweight. Researchers will compare which strategy works best and is most cost-effective.

What this could mean

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

Active substance
balanced energy and protein (BEP) dietary supplement
What this could lead to
If successful, this could show that targeting supplements to undernourished pregnant women is just as effective as giving them to everyone, saving resources and preventing complications like low birth weight.
What could go wrong
This is an effectiveness study, not a drug trial, so the supplement is already known to be safe. However, the results may not apply to other populations or settings, and the targeting strategies might not improve outcomes as hoped.

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

7,851 people

The number who actually took part.

Started

Aug 2023

Finished

Aug 2026

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 49 years

Sex

Female participants only

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: 1. pregnant women aged 18 to 49; 2. attending antenatal visits in one of the study health facilities; 3. with a gestational age of 24 weeks or less; 4. no known allergies to peanuts or soybeans; 5. having resided in the current location for at least 6 months; 6. intending to continue antenatal follow-up in the health facility; 7. intending to give birth and remain in the study area until six weeks after delivery; and 8. willing to take the BEP supplements for the entire duration of the pregnancy if eligible. Exclusion Criteria: * Not meeting all of the inclusion criteria above

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Conditions

The condition(s) this trial relates to.

Birth Weight fetal growth restriction Gestational Weight Gain Perinatal Death pregnancy disorder with abortive outcome Premature Birth Stillbirth

As listed by the trial registrant

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

Birth weight Gestational weight gain Maternal anemia in pregnancy, before birth Neonatal death Perinatal death Preterm birth Small for gestational age at delivery Stillbirth

Contacts and locations

Locations

  • Addis Continental Institute of Public Health (ACIPH)

    Addis Ababa, Addis Ababa, Box 26751/1000, Ethiopia

More trials for these conditions

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