Ferric Carboxymaltose Versus Ferrous Fumarate in Anemic Children with Inflammatory Bowel Disease: The POPEYE Randomized Controlled Clinical Trial

Author links open overlay panel Nanja Bevers MD 1, Els Van de Vijver PhD, MD 2, Arta Aliu 1, Ashkan Rezazadeh Ardabili MD 3, Philippe Rosias MD, PhD 1, Janneke Stapelbroek MD, PhD 4, Imke A. Bertrams Maartens MD 5, Cathelijne van de Feen MD 6, Hankje Escher MD, PhD 7, Annemarie Oudshoorn MD 8, Sarah Teklenburg MD, PhD 9, Saskia Vande Velde MD, PhD 10, Bjorn Winkens PhD 11, Maarten Raijmakers PhD 12, Anita Vreugdenhil MD, PhD 13, Marieke J. Pierik MD, PhD 14, Patrick F. van Rheenen MD, PhD 15


To determine whether intravenous (IV) or oral iron suppletion is superior in improving physical fitness in anemic children with inflammatory bowel disease (IBD).

Study design

We conducted a clinical trial at 11 centers. Children aged 8-18 with IBD and anemia (defined as hemoglobin [Hb] z-score < −2) were randomly assigned to a single IV dose of ferric carboxymaltose or 12 weeks of oral ferrous fumarate. Primary end point was the change in 6-minute walking distance (6MWD) from baseline, expressed as z-score. Secondary outcome was a change in Hb z-score from baseline.


We randomized 64 patients (33 IV iron and 31 oral iron) and followed them for 6 months. One month after the start of iron therapy, the 6MWD z-score of patients in the IV group had increased by 0.71 compared with −0.11 in the oral group (P = .01). At 3- and 6-month follow-ups, no significant differences in 6MWD z-scores were observed. Hb z-scores gradually increased in both groups and the rate of increase was not different between groups at 1, 3, and 6 months after initiation of iron therapy (overall P = .97).


In this trial involving anemic children with IBD, a single dose of IV ferric carboxymaltose was superior to oral ferrous fumarate with respect to quick improvement of physical fitness. At 3 and 6 months after initiation of therapy, no differences were discovered between oral and IV therapies. The increase of Hb over time was comparable in both treatment groups.

Sources: Trial registration NTR4487 [Netherlands Trial Registry]

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