Efficacy, Tolerability, and Acceptability of Iron Hydroxide Polymaltose Complex versus Ferrous Sulfate: A Randomized Trial in Pediatric Patients with Iron Deficiency Anemia

Table 2

Baseline values and changes in erythrocyte-related hematologic and iron status parameters in pediatric patients with iron deficiency anemia receiving oral iron therapy with iron hydroxide polymaltose complex (IPC) or ferrous sulfate.

	IPC; ( 𝑛=52 )			Ferrous sulfate; ( 𝑛=51 )			P value; IPC versus ferrous sulfate
	Value	Change from baseline	P value^a	Value	Change from baseline	P value^a	Absolute value	Change from baseline
Hb (g/dL)
Baseline	9.5 ± 1.10	—	—	9.4 ± 1.6	—	—	0.849	—
1 month	10.6 ± 1.0	1.2 ± 0.9	0.001	11.2 ± 0.9	1.8 ± 1.7	0.001	0.002	0.060
4 months	11.7 ± 0.8	2.3 ± 1.3	0.001	12.4 ± 1.0	3.0 ± 2.3	0.001	0.001	0.349
Hct (%)
Baseline	29.4 ± 2.7	—	—	29.5 ± 4.2	—	—	0.954	—
1 month	32.7 ± 2.2	3.2 ± 2.3	0.001	34.4 ± 2.8	4.9 ± 4.8	0.001	0.001	0.191
4 months	35.5 ± 2.5	6.0 ± 3.3	0.001	37.5 ± 3.2	8.0 ± 6.1	0.001	0.001	0.311
MCV (fL)
Baseline	68.7 ± 7.9	—	—	68.4 ± 8.0	—	—	0.835	—
1 month	71.7 ± 6.8	3.0 ± 3.2	0.001	74.0 ± 5.8	5.7 ± 6.5	0.001	0.061	0.012
4 months	76.3 ± 5.3	7.5 ± 6.7	0.001	79.5 ± 5.8	11.1 ± 8.2	0.001	0.004	0.013
MCH (pg)
Baseline	22.3 ± 3.6	—	—	21.9 ± 3.7	—	—	0.565	—
1 month	23.4 ± 3.1	1.1 ± 1.5	0.001	24.0 ± 2.7	2.1 ± 2.9	0.001	0.276	0.050
4 months	25.2 ± 2.3	2.8 ± 2.7	0.001	26.1 ± 2.6	4.2 ± 3.7	0.001	0.050	0.050
MCHC (%)
Baseline	31.7 ± 1.7	—	—	31.4 ± 2.2	—	—	0.467	—
1 month	32.5 ± 1.4	0.8 ± 1.0	0.001	32.3 ± 1.6	0.9 ± 1.4	0.001	0.446	0.611
4 months	33.5 ± 0.8	1.7 ± 1.4	0.001	33.2 ± 1.2	1.7 ± 1.8	0.001	0.129	0.731
RBC count (×10^12/L)
Baseline	4.3 ± 0.4	—	—	4.2 ± 0.5	—	—	0.705	—
1 month	4.5 ± 0.4	0.2 ± 0.3	0.001	4.6 ± 0.4	0.3 ± 0.4	0.001	0.551	0.675
4 months	4.8 ± 0.4	0.5 ± 0.3	0.001	4.8 ± 0.4	0.6 ± 0.5	0.001	0.550	0.882
TSAT (%)
Baseline	5.1 ± 3.3	—	—	5.4 ± 3.5	—	—	0.864	—
4 months	20.2 ± 15.5	15.2 ± 14.9	0.001	22.4 ± 13.2	17.2 ± 13.3	0.001	0.140	0.284
Serum ferritin (μg/L)
Baseline	10.7 ± 8.5	—	—	7.8 ± 7.6	—	—	0.007	—
4 months	33.4 ± 31.6	22.7 ± 26.1	0.001	50.3 ± 67.3	42.5 ± 62.0	0.001	0.006	0.001
Serum iron (μg/dL)
Baseline	22.2 ± 13.4	—	—	23.2 ± 13.9	—	—	0.746	—
4 months	76.3 ± 60.5	54.2 ± 58.2	0.001	75.7 ± 36.8	52.5 ± 37.7	0.001	0.210	0.432
SIBC (μg/dL)
Baseline	452 ± 68	—	—	447 ± 78	—	—	0.710	—
4 months	379 ± 46	−73 ± 54	0.001	354 ± 52	−93 ± 77	0.001	0.011	0.259

^a𝑃 value for change from baseline.
Data shown as mean ± SD.
Hb: hemoglobin; Hct: hematocrit; IPC: iron hydroxide polymaltose complex; MCH: mean corpuscular hemoglobin; MCV: mean corpuscular volume; MCHC: mean corpuscular hemoglobin concentration; RBC: red blood cell; SIBC: serum iron binding capacity; TSAT: transferrin saturation.