Clinical Burden of Anemia in Inflammatory Bowel Disease: Therapeutic Trial
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
IRCCS Policlinico S. Matteo
Collaborators:
Italian Group for Inflammatory Bowel Diseases (IG-IBD) Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)