Ferric carboxymaltose versus ferrous fumarate in anemic children with inflammatory bowel disease: the POPEYE randomized controlled clinical trial

Department of Paediatrics, Zuyderland Medical Center, Sittard, Netherlands. Electronic address: n.bevers@zuyderland.nl. Department of Paediatric Gastroenterology, Hepatology and Nutrition, Antwerp University Hospital, Edegem, Belgium. Department of Paediatrics, Zuyderland Medical Center, Sittard, Netherlands. Maastricht University Medical Center [MUMC], Department of NUTRIM, Maastricht, The Netherlands. Department of Paediatrics, Zuyderland Medical Centre, Sittard-Geleen, Netherlands. Department of Paediatrics, Catharina Hospital, the Netherlands. Department of Paediatrics, Maxima Medical Centre, Veldhoven, the Netherlands. Department of Paediatrics, Jeroen Bosch Medical Centre, Den Bosch, the Netherlands. Erasmus Medical Center, Children's Hospital Department of Paediatric Gastroenterology, Rotterdam, The Netherlands. Department of Paediatrics, Gelre Hospital, Apeldoorn, the Netherlands. department of Paediatrics, Isala Hospitals, Zwolle, the Netherlands. Ghent University Hospital, Ghent University, Ghent, Belgium. Department of Methodology and Statistics, Maastricht University, Maastricht, Netherlands. Laboratory of Clinical Chemistry and Haematology, Zuyderland Medical Centre, Heerlen, Limburg, The Netherlands. Department of Paediatrics and NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, The Netherlands. Division of Gastroenterology-Hepatology and NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, The Netherlands. University of Groningen, University Medical Centre Groningen - Beatrix Children's Hospital, Department of Paediatric Gastroenterology Hepatology and Nutrition, Groningen, The Netherlands.

The Journal of pediatrics. 2022
PICO Summary

Population

Children with anaemia and inflammatory bowel disease, enrolled in the POPEYE trial, in 9 Dutch and 2 Belgian hospitals (n= 64).

Intervention

Single intravenous dose of ferric carboxymaltose (IV group), (n= 33).

Comparison

12 weeks of oral ferrous fumarate (oral group), (n= 31).

Outcome

The primary endpoint was the change in 6-minute walking distance (6MWD) from baseline, expressed as z-score. The secondary outcome was a change in Hb z-score from baseline. 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. At 3- and 6- months follow-up, 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.
Abstract
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 to 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 endpoint 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; 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=0.01). At 3- and 6-months follow-up, 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=0.97). 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 or IV therapy. The increase of Hb over time was comparable in both treatment groups. TRIAL REGISTRATION NTR4487 [Netherlands Trial Registry].
Study details
Language : eng
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