Ferric Citrate in Iron Deficiency Anemia During Pregnancy

NCT07381426 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: IRB-DMC/2025/291
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

Anemia; Iron deficiency

Outcome Measures

Primary Outcomes (1)

• Hemoglobin concentration

  Change in maternal hemoglobin concentration (g/dL)

  4 weeks

Secondary Outcomes (15)

• Anemia

  36 weeks of gestation and 6 weeks postpartum

• Iron deficiency

  36 weeks of gestation and 6 weeks postpartum

• Health-related quality of life

  4 weeks

• Severe anemia

  6 weeks postpartum

• Serious maternal medical events

  6 weeks postpartum

Study Arms (2)

Ferric citrate

EXPERIMENTAL

Oral ferric citrate 210 mg (providing 210 mg elemental iron daily), administered once daily for 8 weeks.

Drug: Ferric citrate 210 mg

Ferrous fumarate

ACTIVE COMPARATOR

Oral Ferrous fumarate 200 mg (providing 132 mg elemental iron daily), administered twice daily for 12 weeks or until delivery, whichever occurs earlier.

Drug: Ferrous fumarate 200 mg

Interventions

Ferric citrate 210 mg DRUG

Oral ferric citrate 210 mg (providing 210 mg elemental iron daily), administered once daily for 8 weeks.

Ferric citrate

Ferrous fumarate 200 mg DRUG

Oral Ferrous fumarate 200 mg (providing 132 mg elemental iron daily), administered twice daily for 12 weeks or until delivery, whichever occurs earlier.

Ferrous fumarate

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dhaka Medical College: lead
• Sir Salimullah Medical College and Midford Hospital: collaborator
• Mugdha Medical College and Hospital: collaborator
• Shaheed Suhrawardy Medical College and Hospital: collaborator

Study Sites (1)

Dhaka Medical College

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Anemia; Iron Deficiencies

Interventions

ferric citrate; ferrous fumarate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Arifa Sharmin Maya, FCPS, MCPS, FACS, DMU, MBBS

CONTACT

+8801733521479; drarifasharmin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: February 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)