Liposomal Iron Versus Ferrous Sulfate Supplementation in Infants Aged 4 - 6 Months with Iron Deficiency Anemia: A Randomized Controlled Trial

Abstract

Background: Iron deficiency anemia (IDA) remains a major global public health concern, particularly among infants and young children. Conventional iron supplements are effective; however, they are frequently limited by gastrointestinal side effects and poor compliance. Liposomal iron formulations may provide improved absorption and tolerability, but evidence in infants is limited. Objectives: To compare the effects of liposomal iron drops and conventional ferrous sulfate drops on hemoglobin, serum iron (SI), ferritin, total iron-binding capacity (TIBC), mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) in infants aged 4 - 6 months with IDA. Methods: In this single-blind randomized clinical trial, 68 breastfed infants with IDA were allocated to receive either liposomal iron (15 mg/mL elemental iron) or ferrous sulfate (25 mg/mL elemental iron) drops, 1 mL daily for six months in Kermanshah province, Iran. Primary outcomes were changes in hemoglobin, SI, and MCH at 2 and 6 months. Data were analyzed using hierarchical linear models adjusted for baseline values and confounders, with Bonferroni correction for multiple comparisons. Results: Both groups demonstrated significant improvements in hematologic parameters. After adjusting values, liposomal iron resulted in significantly greater marginal increases in hemoglobin (β = 0.35 at 2 months; β = 0.51 at 6 months; both P < 0.05), SI (β = 20.27 µg/dL at 6 months; P < 0.001), and MCH (β = 0.93 pg at 2 months; β = 2.43 pg at 6 months; P < 0.01). The TIBC decreased significantly over time in both groups, with a more pronounced reduction in the liposomal group (-26.6 µg/dL at 2 months; -35.2 µg/dL at 6 months; P < 0.001). Conclusions: Liposomal iron supplementation in infants with IDA resulted in superior improvements in hemoglobin, SI, MCH, and TIBC compared with ferrous sulfate, with similar effects on ferritin and MCV. Its enhanced efficacy suggests it may be a preferable option for pediatric IDA management.