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New iron pill could ease anemia in pregnancy for thousands

NCT ID NCT07381426

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This phase 3 trial in Bangladesh will test whether ferric citrate, a different form of iron, works better and causes fewer stomach problems than the standard ferrous fumarate for pregnant women with moderate to severe iron deficiency anemia. 680 women aged 18-35 in their second trimester will take either ferric citrate once daily for 8 weeks or ferrous fumarate twice daily for up to 12 weeks. The main goal is to see how much hemoglobin levels improve after 4 weeks.

What this could mean

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

Active substance
ferric citrate (an iron supplement)
What this could lead to
If it works, this could provide a better-tolerated iron supplement for pregnant women with anemia, potentially improving adherence and outcomes.
What could go wrong
This is a single-country open-label trial, so results may not apply everywhere. Gastrointestinal side effects are still possible with ferric citrate.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 680 people

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

Started

Feb 2026

Expected to finish

Mar 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

18 to 35 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: * Pregnant women aged 18 to 35 years. * Gestational age between 13 and 26 completed weeks, confirmed by last menstrual period and/or early ultrasound dating. * Diagnosed with moderate to severe iron deficiency anemia (IDA), defined as: Hemoglobin concentration between 7.0 g/dL and \<9.9 g/dL, and Serum ferritin concentration \<30 μg/L * Singleton intrauterine pregnancy confirmed by ultrasonography. * Willing to comply with study procedures and follow-up schedule up to 6 weeks postpartum. * Euthyroid or euthyroid with medications * Normal in anomaly scan * Received ANC check up duly * History of folic acid intake in ANC visit * Willing to conduct delivery at the study center or at a facility within the study catchment area. * No known plans to leave the study area before completion of follow-up. Exclusion Criteria: * Known hypersensitivity or intolerance to ferric citrate, ferrous fumarate, or any excipients in the formulations. * Presence of non-iron deficiency anemia (e.g., megaloblastic anemia, hemoglobinopathies, hemolytic anemia, anemia of chronic disease) estimated by PBF * Baseline hemoglobin concentration \<7.0 g/dL or requiring urgent transfusion according to the best clinical judgement of the consultants * Serum ferritin ≥30 μg/L at baseline. * Severe concurrent medical conditions including: Chronic kidney disease (Stage 3 or higher) Decompensated liver disease Active tuberculosis or other chronic infections Diagnosed malignancy * Pre-existing preeclampsia, or eclampsia, or gestational hypertension * Gestational diabetes or type 2 diabetes mellitus in the current pregnancy. * Multiple pregnancy (e.g., twins, triplets). * Gastrointestinal conditions affecting iron absorption (e.g., inflammatory bowel disease, celiac disease, previous gastric or intestinal surgery). * Use of intravenous iron therapy within previous 2 weeks of the present trial. * Any other condition which, in the opinion of the investigator, may jeopardize the participant's safety or interfere with study outcomes or compliance.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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

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Contacts and locations

Locations

  • Dhaka Medical College

    RECRUITING

    Dhaka, Bangladesh

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