A Randomized Controlled Pilot Study to Compare the Efficacy of Different Iron Formulations: Sucrosomal Ferric Pyrophosphate, Micronized Microencapsulated Ferric Pyrophosphate, and Intravenous Ferric Gluconate

Abstract

Despite their gastrointestinal side effects, oral iron supplements are the first-line therapy in iron deficiency anemia. This study aims to compare different iron formulations in anemic outpatients. One-hundred and six outpatients with sideropenic microcytic hypochromic anemia (Hb < 12 g/dL for women, Hb < 13 g/dL for men) were enrolled and divided into two groups (Hb > 10 g/dL and Hb < 10 g/dL). One group was randomized (1:1) to receive sucrosomal ferric pyrophosphate or micronized microencapsulated ferric pyrophosphate, while the other group was randomized (1:1:1) to receive sucrosomal ferric pyrophosphate, micronized microencapsulated ferric pyrophosphate or intravenous ferric gluconate. After 3 months of follow-up, hemoglobin was significantly higher in the micronized microencapsulated ferric pyrophosphate group than in the sucrosomal ferric pyrophosphate group (1.87 vs 1.10; P = 0.04). No significant difference in adverse events was registered between the two groups. In patients with Hb > 10 g/dL, the pyrophosphate or micronized microencapsulated ferric pyrophosphate (30 mg/day) treatment in combination with folic acid (400 mcg), lactoferrin (10 mg), and vitamin C (180 mg) we found out to bring in a significant increase in hemoglobin, without any significant side effects. The reason for this effectiveness is probably due to its favorable bioavailability. Further comparative studies are needed with other forms of iron.