Comparison of Therapeutic Efficacy of Ferrous Ascorbate and Iron Polymaltose Complex in Iron Deficiency Anemia in Children: A Randomized Controlled Trial.

Abstract

To compare the therapeutic efficacy of Ferrous ascorbate (FA) and Iron polymaltose complex (IPC) in Iron deficiency anemia (IDA) in children. A randomized controlled trial (RCT) was conducted at a tertiary care hospital with 125 (1-12 y) children having clinical symptoms and signs of IDA. Participants were randomized into FA group and IPC group. Both the groups received iron salts (FA or IPC) randomly in a dose of 6mg/kg elemental iron for 3 mo and followed up on day 3, day 7, at the end of 1 mo and 3 mo for Hemoglobin (Hb), Mean corpuscular volume (MCV), Red cell distribution width (RDW) and reticulocyte count. Both groups had an improvement in hematological parameters at 3 mo of intervention. The difference in the rise of Hb (g%) at the end of 1 mo in FA group (3.13 ± 1.01) vs. IPC group (2.0 ± 0.85); p = 0.017 and at 3 mo in FA group (4.88 ± 1.28) vs. IPC group (3.33 ± 1.33); p = 0.001 was statistically significant. The difference in the rise of mean Hb was significantly better in FA than the IPC group F [3392] =1.79; p = 0.00 (ANOVA). The difference in the mean increase in MCV (fL) at day 7 in FA group (6.71 ± 8.32) vs. IPC group (2.91 ± 6.16); p = 0.011 and at 1 mo FA group (9.80 ± 8.56) vs. IPC group (5.35 ± 6.11); p = 0.004 was statistically significant. The mean decrease in RDW (%) at 1 mo in FA group (4.23 ± 3.27) vs. IPC group (2.67 ± 1.95); p = 0.005 and at 3 mo in FA group (5.74 ± 3.63) vs. IPC group (4.04 ± 2.17); p = 0.006 was statistically significant. The difference in the rise in mean reticulocyte count at day 3 in FA group (0.88 ± 0.50) vs. IPC group (0.43 ± 1.20); p = 0.017 and at day 7 in FA group (4.00 ± 1.69) vs. IPC group (2.19 ± 1.24); p = 0.001 was statistically significant. F [2294] = 29.2, p = 0.00 (ANOVA). During the study period, the FA group had minor adverse reactions whereas the IPC group had none. Both the iron salts (FA and IPC) used in the treatment of IDA showed statistically significant improvement in the hematological parameters during the 3 mo of intervention. The improvement in hematological parameters was better in FA supplemented patients as compared to IPC.