Ferric citrate for iron deficiency anemia in pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, open-label, randomized trial will enroll pregnant women aged 18-35 in the second trimester who have moderate to severe iron deficiency anemia. Participants will be assigned to ferric citrate 210 mg or ferrous fumarate 200 mg in a two-arm, parallel-group design to assess efficacy and safety up to 6 weeks postpartum. The study is conducted at multiple Dhaka-based centers with standard prenatal care and follow-up procedures. Primary outcomes focus on hematologic response and safety signals, including adverse events and tolerability. The aim is to determine whether ferric citrate offers better tolerability or effectiveness compared to ferrous fumarate in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dhaka Medical College
  Dhaka, Bangladesh Recruiting

Study contacts

• Study coordinator: Arifa Sharmin Maya, FCPS, MCPS, FACS, DMU, MBBS
• Email: drarifasharmin@gmail.com
• Phone: +8801733521479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.