๐ฌIn plain words
What the trial is, and whether it could suit you
Maternal anemia remains a significant public health concern in low and middle income countries including Bangladesh, contributing to adverse maternal and neonatal outcomes. Despite the widespread use of oral ferrous fumarate, gastrointestinal intolerance and suboptimal adherence remain persistent challenges, indicating the need for alternative iron formulations with improved efficacy and safety profiles. Hence, this study aims to evaluate the efficacy and safety of oral ferric citrate compared to oral ferrous fumarate in the management of maternal iron deficiency anemia during second trimester of pregnancy.
This phase 3, open-label, two-arm, parallel-group randomized controlled trial will be conducted among pregnant women aged 18-35 years, with gestational age between 13 and 26 weeks, diagnosed with moderate to severe iron deficiency anemia (hemoglobin 7-9.9 g/dL and serum ferritin \<30
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 ฮผg/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 โฅ30 ฮผg/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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What it tests
- Ferric citrate 210 mg
- Ferrous fumarate 200 mg
Dhaka Medical College
Dhaka, Bangladesh
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.