New iron pill could ease anemia in pregnancy for thousands
NCT ID NCT07381426
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 680 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 35 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Dhaka Medical College
RECRUITINGDhaka, Bangladesh
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