Ferric Carboxymaltose Versus Ferrous Fumarate in Anemic Children with Inflammatory Bowel Disease: The POPEYE Randomized Controlled Clinical Trial.
Bevers, Nanja MD 1,*; Van de Vijver, Els PhD, MD 2; Aliu, Arta 1; Ardabili, Ashkan Rezazadeh MD 3; Rosias, Philippe MD, PhD 1; Stapelbroek, Janneke MD, PhD 4; Bertrams Maartens, Imke A. MD 5; van de Feen, Cathelijne MD 6; Escher, Hankje MD, PhD 7; Oudshoorn, Annemarie MD 8; Teklenburg, Sarah MD, PhD 9; Velde, Saskia Vande MD, PhD 10; Winkens, Bjorn PhD 11; Raijmakers, Maarten PhD 12; Vreugdenhil, Anita MD, PhD 13; Pierik, Marieke J. MD, PhD 14; van Rheenen, Patrick F. MD, PhD 15
[Article]
Journal of Pediatrics.
256:113-119,119e1-119e4, May 2023.
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Objective: 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.
Results: 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).
Conclusion: 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.
Trial registration: NTR4487 [Netherlands Trial Registry].
(C) 2023Elsevier, Inc.