Safety and efficacy of liposomal iron for iron deficiency anemia in pediatric population: A systematic review and meta-analysis of randomized controlled trials.

Iron deficiency anemia (IDA) remains a public health problem in children. Conventional iron therapy is effective but often causes gastrointestinal adverse effects that reduce adherence. Liposomal iron has been developed to enhance absorption and improve tolerability. This systematic review and meta-analysis evaluated the efficacy and safety of liposomal iron compared with conventional iron formulations in pediatric patients with IDA. We searched PubMed, Scopus, Web of Science, and the Cochrane Library up to February 21, 2026 for randomized controlled trials (RCTs) comparing liposomal iron with conventional oral iron in children with IDA. Analyses were performed using R software with the meta package. Continuous outcomes were pooled as mean differences (MDs) and dichotomous outcomes as risk ratios (RRs) with 95% confidence intervals (CIs) using a random-effects model. Subgroup analyses according to follow-up duration. Four RCTs involving 454 children were included. At 6 months, liposomal iron produced a significantly greater increase in hemoglobin compared with conventional iron (MD 0.96 g/dL, 95% CI 0.09-1.82; P = 0.03), although heterogeneity was substantial (I2 = 92.9%). No significant differences were observed at earlier time points. Liposomal iron significantly reduced total iron-binding capacity (MD - 35.52 μg/dL; P < 0.0001) and increased mean corpuscular hemoglobin (MD 1.83 pg; P < 0.0001). Liposomal iron was associated with fewer adverse events (RR 0.29; P = 0.02) and lower risk of constipation (RR 0.56; P = 0.02).

Conclusion

Liposomal iron offered better tolerability and was non-inferior to conventional iron for most hematologic outcomes. Evidence remains preliminary and larger RCTs are needed to confirm its efficacy in pediatric IDA.