Introduction 

Iron-deficiency anemia (IDA) is a common pediatric health problem that adversely affects hematologic status, growth, and development. Liposomal iron is a novel ferric pyrophosphate formulation with improved bioavailability and gastrointestinal tolerability compared with conventional oral iron preparations. 

Aim

To compare the efficacy and safety of oral liposomal iron versus conventional oral iron (iron polymaltose complex) in children aged 2-12 years with IDA. 

Patient Profile

• 192 children aged 2-12 years diagnosed with IDA (Hb <11 g/dL). 
• Serum ferritin at enrollment ranged from 7.5-13 ng/mL. 
• No iron supplementation or blood transfusion within the previous 3 months. 

Methods

Study design

• Prospective, randomized controlled trial 

Population

• Liposomal iron group: n=96.
• Conventional iron polymaltose complex group: n=96. 

Treatment

• Liposomal iron: 1.4 mg/kg/day orally, once daily after meals.
• Iron polymaltose complex: 6 mg/kg/day orally, once daily after meals.
• Treatment duration: 6 months. 

Endpoints

• Primary endpoint: Improvement in hematological parameters and iron profile after 1 month.
• Secondary endpoints: Changes in anthropometric measures (particularly weight z-score), hematologic parameters, and iron profile after 6 months; assessment of adverse events and compliance. 

Results

• Liposomal iron produced significantly greater improvements in hematologic and iron profile parameters after 1 month. 
• RDW and platelet counts were also significantly lower versus conventional iron (P=0.003 & P=0.038, respectively). 

Table 1. One-Month Efficacy Outcomes

Parameter	Liposomal Iron (n=96)	Conventional Iron (n=96)	P value
Hb (g/dL)	12.12±0.95	11.9±0.57	<0.001
Hematocrit (%)	34.73±3.06	33.87±1.46	0.015
MCV (fL)	80.43±6.10	75.58±2.69	<0.001
MCH (pg)	27.89±2.74	26.93±2.08	0.006
Serum iron (μg/dL)	73.4±6.56	64.32±5.07	<0.001
Ferritin (ng/mL)	29.52±11.65	23.05±2.62	<0.001
TIBC (μg/dL)	333.08±51.33	359.60±27.99	<0.001
Transferrin saturation	0.26±0.05	0.23±0.03	<0.001

 

• Six months of liposomal iron resulted in sustained superiority across hematologic and iron-storage parameters. 
• RDW and platelet counts remained significantly lower than with conventional iron (both P≤0.015). 

Table 2. Six-Month Efficacy Outcomes

Parameter	Liposomal Iron	Conventional Iron	P value
Hb (g/dL)	13.32±1.50	12.13±0.59	<0.001
Hematocrit (%)	39.24±4.86	36.88±1.70	<0.001
MCV (fL)	89.21±7.72	78.79±2.62	<0.001
MCH (pg)	30.74±3.84	28.61±1.93	<0.001
Serum iron (μg/dL)	86.68±15.00	68.60±6.20	<0.001
Ferritin (ng/mL)	39.62±16.55	25.86±2.62	<0.001
TIBC (μg/dL)	312.85±56.16	346.60±27.79	<0.001
Transferrin saturation	0.37±0.12	0.27±0.04	<0.001

 

Anthropometric Outcomes

One Month

• Weight: 18.66±5.00 vs 17.19±5.15 kg (P=0.047).
• Weight z-score: 0.09±0.99 vs -0.18±0.68 (P=0.040).
• BMI: 17.83±1.70 vs 17.35±1.53 kg/m² (P=0.045). 

At 6 months, liposomal iron was associated with greater 

• Weight: 20.5±4.3 vs 19.13±4.90 kg (P=0.045).
• Weight z-score: 0.49±1.02 vs 0.20±0.78 (P<0.001).
• Height: 105.17±15.11 vs 101.00±13.13 cm (P=0.043).
• Height z-score: -0.21±1.41 vs -0.56±1.70 (P=0.042).
• BMI: 18.56±1.68 vs 17.97±1.63 kg/m² (P=0.014).
• BMI z-score: 1.67±0.73 vs 1.24±1.12 (P=0.038). 

Adverse Events

Adverse Event	Liposomal Iron (%)	Conventional Iron (%)
No adverse effects	94.8	75.0
Constipation	3.1	8.3
Black stools	2.1	6.3
Abdominal pain	0	3.1
Teeth staining	0	3.1
Constipation + black stools	0	4.2

Overall, between-group difference: P<0.001

Conclusion

• Oral liposomal iron produced significantly greater improvements in hemoglobin, iron profile parameters, and growth-related anthropometric measures than conventional iron polymaltose complex at both 1 and 6 months. 
• Liposomal iron demonstrated superior tolerability, with fewer gastrointestinal adverse events, improved compliance, and potential benefits for growth in children with IDA. 

Reference 

Clin Exp Pediatr 2025; 68; 8: 608–615.