AnemiaPhase 3NCT07381426
Ferric Citrate in Iron Deficiency Anemia During Pregnancy
A Phase 3 study testing Ferric citrate 210 mg and Ferrous fumarate 200 mg in people with Anemia, run by Dhaka Medical College at 1 site in Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Anemia
- What is being tested?
- Ferric citrate 210 mg and Ferrous fumarate 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Feb 2026to 31 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Dhaka Medical College
Dhaka
Arifa Sharmin Maya, FCPS, MCPS, FACS, DMU, MBBS, +8801733521479, drarifasharmin@gmail.com
About this study
Official title: Efficacy and Safety of Ferric Citrate in Iron Deficiency Anemia During the Second Trimester of Pregnancy in Bangladesh: A Randomized Controlled Trial
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.
Read more
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
- Being tested
- Ferric citrate 210 mg, Ferrous fumarate 200 mg
- Keywords
- Anemia, Iron deficiency
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric citrate 210 mgDrug
Oral ferric citrate 210 mg (providing 210 mg elemental iron daily), administered once daily for 8 weeks.
Ferrous fumarate 200 mgDrug
Oral Ferrous fumarate 200 mg (providing 132 mg elemental iron daily), administered twice daily for 12 weeks or until delivery, whichever occurs earlier.
| Study group | Role | What they receive |
|---|---|---|
| Ferric citrate | Experimental | Oral ferric citrate 210 mg (providing 210 mg elemental iron daily), administered once daily for 8 weeks. Receives: 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. Receives: Drug: Ferrous fumarate 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin concentration
Change in maternal hemoglobin concentration (g/dL)
Measured: 4 weeks
Secondary outcomes (15)
Anemia
Prevalence of maternal anemia (Hb <11g/dL)
Measured: 36 weeks of gestation and 6 weeks postpartum
Iron deficiency
Prevalence of maternal iron deficiency (serum ferritin concentration <30 μg/L)
Measured: 36 weeks of gestation and 6 weeks postpartum
Health-related quality of life
Change in maternal health-related quality of life (HRQoL) will be assessed using the EuroQol five-dimension, five-level questionnaire (EQ-5D-5L), a standardized instrument that evaluates five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a five-level ordinal scale ranging from level 1 (no problems) to level 5 (extreme problems), generating a five-digit health state that represents the respondent's self-reported health status.
Raw EQ-5D-5L health states will subsequently be converted into a single summary index score using the country-specific value set for Bangladesh. The EQ-5D-5L index score ranges from values below 0, representing health states considered worse than death, to 1.0, representing full health. Higher index scores indicate better health-related quality of life. Changes in the EQ-5D-5L index score will be used to quantify changes in maternal HRQoL over the study period.
Measured: 4 weeks
Severe anemia
Incidence of severe anemia requiring blood transfusion during gestation, delivery, or the puerperium
Measured: 6 weeks postpartum
Serious maternal medical events
Incidence of serious maternal medical events, including:
Antepartum or postpartum hemorrhage Sepsis or septic shock Intensive care unit (ICU) admission Prolonged hospital stay Wound infection confirmed by positive growth in culture of wound swab Maternal mortality
Measured: 6 weeks postpartum
Neonatal birth weight
Neonatal birth weight will be measured at birth (in grams)
Measured: At birth
Placental weight
Placental weight will be measured after delivery (in grams)
Measured: At birth
Gestational age-adjusted birth weight
Gestational age-adjusted birth weight will be measured at birth (in grams)
Measured: At birth
Incidence of abortion
Incidence of abortion
Measured: through study completion, an average of 20 weeks
Incidence of stillbirth
Incidence of stillbirth
Measured: During delivery
Incidence of preterm birth
Incidence of preterm birth
Measured: During delivery
Cord venous blood hemoglobin concentration
Cord venous blood hemoglobin concentration (g/dL) will be measured from umbilical cord blood samples collected immediately after delivery
Measured: At birth
Cord venous blood ferritin concentration
Cord venous blood ferritin concentration (ng/mL) will be measured from umbilical cord blood samples collected immediately after delivery.
Measured: At birth
Infant hemoglobin concentration
Infant hemoglobin concentration (g/dL) will be measured from peripheral venous blood samples collected at the 6-week of age
Measured: 6 weeks after birth
Infant serum ferritin concentration
Infant serum ferritin concentration (ng/mL) will be measured from peripheral venous blood samples collected at 6 weeks of age
Measured: 6 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dhaka Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Salimullah Medical College and Midford Hospital, Mugdha Medical College and Hospital, Shaheed Suhrawardy Medical College and Hospital
- Responsible party
- Principal investigator, Arifa Sharmin Maya, Dhaka Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381426
- Sponsor's protocol ID
- IRB-DMC/2025/291
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared on a reasonable request to the PI.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ferric Citrate in Iron Deficiency Anemia During the Second Trimester of Pregnancy in Bangladesh: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07381426
- Acronym / sponsor ID
- IRB-DMC/2025/291
- Conditions
- Anemia
- Keywords
- Anemia, Iron deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Dhaka Medical CollegeUniversity, hospital or other
- Collaborators
- Sir Salimullah Medical College and Midford Hospital, Mugdha Medical College and Hospital, Shaheed Suhrawardy Medical College and Hospital
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric citrate | Experimental | Drug: Ferric citrate 210 mgOral ferric citrate 210 mg (providing 210 mg elemental iron daily), administered once daily for 8 weeks. |
| Ferrous fumarate | Active comparator | Drug: Ferrous fumarate 200 mgOral Ferrous fumarate 200 mg (providing 132 mg elemental iron daily), administered twice daily for 12 weeks or until delivery, whichever occurs earlier. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric citrate 210 mgOral ferric citrate 210 mg (providing 210 mg elemental iron daily), administered once daily for 8 weeks. | Drug | Ferric citrate |
| Ferrous fumarate 200 mgOral 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 |
Primary outcome
Hemoglobin concentration
Time frame: 4 weeks
Change in maternal hemoglobin concentration (g/dL)
15 secondary outcomes
Anemia
Time frame: 36 weeks of gestation and 6 weeks postpartum
Iron deficiency
Time frame: 36 weeks of gestation and 6 weeks postpartum
Health-related quality of life
Time frame: 4 weeks
Severe anemia
Time frame: 6 weeks postpartum
Serious maternal medical events
Time frame: 6 weeks postpartum
Neonatal birth weight
Time frame: At birth
Placental weight
Time frame: At birth
Gestational age-adjusted birth weight
Time frame: At birth
Incidence of abortion
Time frame: through study completion, an average of 20 weeks
Incidence of stillbirth
Time frame: During delivery
Incidence of preterm birth
Time frame: During delivery
Cord venous blood hemoglobin concentration
Time frame: At birth
Cord venous blood ferritin concentration
Time frame: At birth
Infant hemoglobin concentration
Time frame: 6 weeks after birth
Infant serum ferritin concentration
Time frame: 6 weeks after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. IPD will be shared on a reasonable request to the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric citrate 210 mg and Ferrous fumarate 200 mg in people with Anemia, run by Dhaka Medical College at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arifa Sharmin Maya, FCPS, MCPS, FACS, DMU, MBBS (+8801733521479, drarifasharmin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin concentration (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.