Table of Contents Author Guidelines Submit a Manuscript
International Journal of Pediatrics
Volume 2011, Article ID 524520, 6 pages
http://dx.doi.org/10.1155/2011/524520
Clinical Study

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

Department of Pediatric Hematology/Oncology, Istanbul Medical School, University of Istanbul, Capa 34093, Istanbul, Turkey

Received 23 August 2011; Accepted 29 September 2011

Academic Editor: Frans J. Walther

Copyright © 2011 Beril Yasa et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Iron polymaltose complex (IPC) offers similar efficacy with superior tolerability to ferrous sulfate in adults, but randomized trials in children are rare. In a prospective, open-label, 4-month study, 103 children aged >6 months with iron deficiency anemia (IDA) were randomized to IPC once daily or ferrous sulfate twice daily, (both 5 mg iron/kg/day). Mean increases in Hb to months 1 and 4 with IPC were 1 . 2 ± 0 . 9  g/dL and 2 . 3 ± 1 . 3  g/dL, respectively, (both 𝑃 = 0 . 0 0 1 versus baseline) and 1 . 8 ± 1 . 7  g/dL and 3 . 0 ± 2 . 3  g/dL with ferrous sulfate (both 𝑃 = 0 . 0 0 1 versus baseline) (n.s. between groups). Gastrointestinal adverse events occurred in 26.9% and 50.9% of IPC and ferrous sulfate patients, respectively ( 𝑃 = 0 . 0 1 2 ). Mean acceptability score at month 4 was superior with IPC versus ferrous sulfate ( 1 . 6 3 ± 0 . 5 6 versus 2 . 1 4 ± 0 . 7 5 , 𝑃 = 0 . 0 0 1 ). Efficacy was comparable with IPC and ferrous sulfate over a four-month period in children with IDA, but IPC was associated with fewer gastrointestinal adverse events and better treatment acceptability.