Clinical Burden of Anemia in Inflammatory Bowel Disease (RIDART1) (RIDART-1)

NCT02872376 COMPLETED

Anemia is the most common extraintestinal manifestation of IBD, occurring in 6 to 74 percent of patients. Most cases of anemia in IBD are due to iron deficiency (IDA) and to anemia of inflammation (AI). Although the ECCO diagnostic criteria for IDA are simple, and iron supplementation represents a cheap and usually effective treatment, many IBD patients with IDA are not properly treated. The inconsistent adherence, by many physicians, to treatment guidelines for IDA in IBD is often motivated by the belief that mild to moderate degrees of anemia may not have a significant impact on the patient's quality of life or do not represent the main clinical problem of the patient, that oral iron supplementation may adversely affect disease activity, and that parenteral iron administration may cause severe side effects. On this basis, we aim to perform a longitudinal, prospective, observational study whose main objective is the determination of the prevalence of anemia in IBD patients in Italy. Secondary objectives of the study are a) to investigate the pathogenesis of anemia in IBD, with a particular focus on the differential diagnosis between IDA and AI, and how disease activity, extension or behavior influence the relative frequency of IDA and AI; b) to verify the adherence to ECCO guidelines for the treatment of IDA in IBD (the proportion of patients with IDA that receive adequate iron supplementation); c) to administer dedicated questionnaires to the patients in order to measure the influence of anemia on fatigue and quality of life among IBD patients.

Details

Lead sponsor	Fondazione IRCCS Policlinico San Matteo di Pavia
Status	COMPLETED
Enrolment	740
Start date	Thu Sep 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Dec 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Anemia

Countries

Italy