A Phase 3 interventional study of Ferric citrate 210 mg and Ferrous fumarate 200 mg in Anemia, sponsored by Dhaka Medical College. Recruiting at 1 site in Bangladesh. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Dhaka Medical College · Phase 3, Interventional, and Treatment
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 680 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →Dhaka Medical College is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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concentration between 7.0 g/dL and \<9.9 g/dL, and Serum ferritin concentration \<30 μg/L
Exclusion Criteria:
Chronic kidney disease (Stage 3 or higher) Decompensated liver disease Active tuberculosis or other chronic infections Diagnosed
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral ferric citrate 210 mg (providing 210 mg elemental iron daily), administered once daily for 8 weeks.
Drug: Ferric citrate 210 mg
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
Oral ferric citrate 210 mg (providing 210 mg elemental iron daily), administered once daily for 8 weeks.
Oral Ferrous fumarate 200 mg (providing 132 mg elemental iron daily), administered twice daily for 12 weeks or until delivery, whichever occurs earlier.
Hemoglobin concentration
Change in maternal hemoglobin concentration (g/dL)
Time frame: 4 weeks
Anemia
Prevalence of maternal anemia (Hb \<11g/dL)
Time frame: 36 weeks of gestation and 6 weeks postpartum
Iron deficiency
Prevalence of maternal iron deficiency (serum ferritin concentration \<30 μg/L)
Time frame: 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.
Time frame: 4 weeks
Severe anemia
Incidence of severe anemia requiring blood transfusion during gestation, delivery, or the puerperium
Time frame: 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
Time frame: 6 weeks postpartum
Neonatal birth weight
Neonatal birth weight will be measured at birth (in grams)
Time frame: At birth
Placental weight
Placental weight will be measured after delivery (in grams)
Time frame: At birth
Gestational age-adjusted birth weight
Gestational age-adjusted birth weight will be measured at birth (in grams)
Time frame: At birth
Incidence of abortion
Incidence of abortion
Time frame: through study completion, an average of 20 weeks
Incidence of stillbirth
Incidence of stillbirth
Time frame: During delivery
Incidence of preterm birth
Incidence of preterm birth
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 6 weeks after birth
Plan to share: No — IPD will be shared on a reasonable request to the PI.
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Studies of the drug tested here: Ferric citrate
Dhaka Medical College