Efficacy and Safety of Oral Liposomal Versus Conventional Iron in Anemic Children With CKD Stage 3-5, not on Hemodialysis: A Randomized Controlled Trial

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Rationale & Objective Anemia in pediatric chronic kidney disease (CKD) is common which adds to morbidity, reduced quality of life, and increased cardiovascular risk. Conventional oral iron is limited by poor absorption, poor adherence, and high hepcidin level. Liposomal iron (iron pyrophosphate encapsulated within a phospholipid membrane) has enhanced iron bioavailability. This study evaluates whether liposomal iron is superior to conventional oral iron in pediatric CKD-associated anemia. Study Design A single-center, open-label, randomized controlled trial. Setting & Participants Conducted at PGIMER, Chandigarh (February–September 2024) with 68 CKD stages 3-5 participants, ≤14 years, and not treated with hemodialysis. Exposure Participants randomized into conventional oral iron (group 1) or liposomal iron (group 2) were assessed at enrolment and after 12 weeks for hemoglobin and iron profile (serum iron, total iron-binding capacity, ferritin, and transferrin saturation [TSAT]). Outcomes Primary outcome was mean change in hemoglobin from baseline to 12 weeks. Secondary outcomes included changes in iron profile, hepcidin, and adverse events. Analytical Approach Intention-to-treat analysis with appropriate parametric or nonparametric test for intergroup and intragroup comparison ( P < 0.05 significant). Results Baseline hemoglobin levels were comparable (9.3 ± 1.2 g/dL in group 1 vs 9.1 ± 1.4 g/dL in group 2; P = 0.88). After 12 weeks, hemoglobin increased by 1.2 g/dL in group 2 versus 0.6 g/dL in group 1, though not statistically significant ( P = 0.28). Serum iron significantly increased in group 2 (55.7 ± 18.2 to 70.7 ± 19.9 mcg/dL; P = 0.03). Further, TSAT improved significantly in group 2 (22.6 ± 15.6% to 30.2 ± 12.6%; P = 0.05). Ferritin, total iron-binding capacity, and hepcidin levels showed no significant changes. Adverse event incidence was lower in group 2 (19.4%) as compared with group 1 (43.7%). Limitations Single-center design, open label study, and short follow-up. Conclusions In anemic children with CKD not treated with hemodialysis, liposomal iron is not better than conventional iron in improving the hemoglobin level. However, serum iron and TSAT improved significantly with liposomal iron accompanied by fewer adverse events. Longer follow-up studies are required to recognize the efficacy of liposomal iron in this cohort. Plain-Language Summary This randomized controlled trial evaluates the efficacy and tolerability of oral liposomal iron compared to conventional oral iron in pediatric patients with chronic kidney disease, not treated with hemodialysis. Given the significant burden of anemia in pediatric patients with CKD and the limitations of conventional iron therapy due to poor bioavailability and gastrointestinal side effects, our study provides clinically relevant insights into an alternative oral iron formulation with potentially superior absorption, better compliance, and fewer side effects. The key findings of our study include: Greater improvement in hemoglobin levels with liposomal iron compared with conventional iron, though not statistically significant; significant improvement in serum iron and transferrin saturation levels in the liposomal iron group, suggesting enhanced bioavailability and reduced adverse effects accompanied by better adherence with liposomal iron, which may improve long-term treatment outcomes in pediatric patients with CKD. Our study supports the potential role of liposomal iron as an alternative to traditional iron formulations.