Efficacy and safety of emulsified microsomal ferric pyrophosphate vs. Ferrous Ascorbate in pregnancy with iron-deficiency anemia- a randomized, comparative study.

This study evaluates the efficacy and safety of emulsified microsomal Ferric pyrophosphate (EMFP/SunActive™ Fe, 27 mg elemental iron) versus Ferrous Ascorbate (100 mg elemental iron) in second-trimester pregnant women with iron-deficiency anemia (IDA) for 4 weeks. Pregnant women aged 20-35 years with a singleton pregnancy, hemoglobin (Hb) 9-10.5 g/dL, and ferritin < 15 mcg/L were enrolled. The test group showed zero adverse effects vs. the control group, having 11.1% adverse events. The gastrointestinal(GI) adverse symptoms, including nausea, dark stools, and hyperacidity, were reported only in the Ferrous Ascorbate group, indicating superior tolerability and safety of EMFP tablets. Both groups showed similar improvements in Hb (Δ2.63 g/dL vs. Δ2.62 g/dL) and serum ferritin (61.09% vs. 61.92%). Reticulocyte hemoglobin (RET-He) increased by 20.5% in the test group and 16.2% in the control group, with no significant difference. Clinical symptoms such as dizziness, fatigue, and palpitations improved with greater magnitude in the test group. It was inferred that the test group receiving EMFP was as effective as the control group in improving efficacy endpoints at a significantly lower dose (1/3rd dose compared to ascorbate). EMFP showed better tolerability, safety and compliance, making it a promising option for managing IDA in pregnant women.