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NCT07381426
Ferric Citrate in Iron Deficiency Anemia During Pregnancy
Conditions: Anemia
Sex: Female
Ages: 18 Years – 35 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 680
Sponsor: Dhaka Medical College
Location: Dhaka Medical College Dhaka
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 \
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 \
Source: ClinicalTrials.gov (NCT07381426). StuddyBuddy aggregates publicly available trial information.