Clinical Burden of Anemia in Inflammatory Bowel Disease: Therapeutic Trial

Summary

Anemia is the most common extraintestinal manifestation of inflammatory bowel diseases (IBD), Although most cases of anemia in IBD are due to iron deficiency, many patients with iron deficiency anemia (IDA) are not treated with iron supplementation. In addition, it has not been firmly established which iron supplementation modality provides the best results in terms of effectiveness and safety. In the present study the investigators will compare the effectiveness and efficacy of three iron supplementation modalities in IBD-associated IDA. There will be two arms of parenteral (iv) iron supplementation (ferric carboxymaltose and ferric gluconate) and one arm of oral supplementation (sucrosomial iron). Primary objective of the study is is to compare the efficacy of oral iron with that of the iv iron supplementation regimens. The primary outcome is measured as the percentage of patients responsive to iron supplementation. Response is defined by Hb normalization or by an Hb increase ≥2 g/dL by week 8 from start of therapy. As secondary objectives the influence of anemia and its treatment on fatigue, quality of life, hospitalizations, additional outpatient visits, number of endoscopic examinations; further treatments and relative side effects will be evaluated.

Timeline

Start

2020-01-01

Primary completion

2023-06-30

Completion

2023-06-30

Publications

• Background Nutritional anaemias. Report of a WHO scientific group. World Health Organ Tech Rep Ser. 1968;405:5-37. No abstract available.
• Background Dignass AU, Gasche C, Bettenworth D, Birgegard G, Danese S, Gisbert JP, Gomollon F, Iqbal T, Katsanos K, Koutroubakis I, Magro F, Savoye G, Stein J, Vavricka S; European Crohn's and Colitis Organisation [ECCO]. European consensus on the diagnosis and management of iron deficiency and anaemia in inflammatory bowel diseases. J Crohns Colitis. 2015 Mar;9(3):211-22. doi: 10.1093/ecco-jcc/jju009. Epub 2014 Dec 3. No abstract available.
• Background Ciccocioppo R, Klersy C, Russo ML, Valli M, Boccaccio V, Imbesi V, Ardizzone S, Porro GB, Corazza GR. Validation of the Italian translation of the Inflammatory Bowel Disease Questionnaire. Dig Liver Dis. 2011 Jul;43(7):535-41. doi: 10.1016/j.dld.2010.12.014. Epub 2011 Feb 18.
• Background Bergamaschi G, Di Sabatino A, Albertini R, Ardizzone S, Biancheri P, Bonetti E, Cassinotti A, Cazzola P, Markopoulos K, Massari A, Rosti V, Porro GB, Corazza GR. Prevalence and pathogenesis of anemia in inflammatory bowel disease. Influence of anti-tumor necrosis factor-alpha treatment. Haematologica. 2010 Feb;95(2):199-205. doi: 10.3324/haematol.2009.009985. Epub 2009 Oct 8.

Drugs

Indications