NCT07381426 Ferric Citrate in Iron Deficiency Anemia During Pregnancy
| NCT ID | NCT07381426 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Dhaka Medical College |
| Condition | Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 680 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 680 participants in total. It began in 2026-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 μg/L). Exclusion criteria are non-iron deficiency anemia, multiple pregnancy, severe comorbidities, and recent intravenous iron therapy. Eligible participants will be randomized in a 1:1 ratio to receive either oral ferric citrate 210 mg (210 mg elemental iron) once daily for 8 weeks or oral ferrous fumarate 200 mg (66 mg elemental iron) twice daily for 12 weeks or until delivery, whichever occurs earlier. The primary endpoint is the change in maternal hemoglobin concentration from baseline to week 4 of randomization. Secondary endpoints include maternal outcome such as prevalence of anemia and iron deficiency at 36 weeks gestation and at 6 weeks postpartum, changes in maternal health-related quality of life (assessed by EQ-5D-5L), incidence of severe anemia requiring transfusion, and serious maternal medical events and neonatal outcomes such as birth weight, placental weight, birth weight percentiles, rates of low birth weight, abortion, stillbirth, preterm birth, and cord blood hemoglobin and ferritin levels, as well as infant hemoglobin and iron indices at 6 weeks of age. Safety endpoints will include incidence of adverse events, serious adverse events, maternal sick visits during the follow-up period. Ethical approval for this trial was obtained from the institutional review boards of Dhaka Medical College, and written informed consent will be secured from all participants prior to enrollment. The findings from this trial are expected to inform clinical guidelines by establishing whether ferric citrate offers a clinically advantageous alternative to Ferrous fumarate for managing iron deficiency anemia during pregnancy.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07381426 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 35 Years, studying Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07381426 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 680 participants.
Is NCT07381426 currently recruiting?
Yes, NCT07381426 is actively recruiting participants. Contact the research team at drarifasharmin@gmail.com for enrollment information.
Where is the NCT07381426 trial being conducted?
This trial is being conducted at Dhaka, Bangladesh.
Who is sponsoring the NCT07381426 clinical trial?
NCT07381426 is sponsored by Dhaka Medical College. The trial plans to enroll 680 participants.