Clinical Burden of Anemia in Inflammatory Bowel Disease (RIDART1)

NCT02872376 | Completed

• 1 other identifier: RIDART-I
• Study Type: observational
• Target: 740
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia

Keywords

Anemia; Crohn's disease; Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Ratio of the number of anemic patients over the number of patients screened for anemia

  The primary outcome will be computed as the ratio of the number of anemic patients over the number of patients screened for anemia together with its 95% confidence interval

  12 months

Secondary Outcomes (3)

• Ratio between the number of patients with IDA or with AI over the total number of anemic patients

  12 months

• IBDQ

  12 months

• Number of hospitalizations in anemic patients

  12 months

Study Arms (1)

Anemic

Anemic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with inflammatory bowel disease and anemia

You may qualify if:

• Have given written informed consent to participate
• Be aged 18 years and over
• Have IBD and anemia

You may not qualify if:

• \- IBD patients without anemia

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (1)

• Bergamaschi G, Castiglione F, D'Inca R, Astegiano M, Fries W, Milla M, Ciacci C, Rizzello F, Saibeni S, Ciccocioppo R, Orlando A, Bossa F, Principi M, Vernia P, Ricci C, Scribano ML, Bodini G, Mazzucco D, Bassotti G, Riegler G, Buda A, Neri M, Caprioli F, Monica F, Manca A, Villa E, Fiorino G, Comberlato M, Aronico N, Della Corte C, Caccaro R, Gionchetti P, Giuffrida P, Iovino P, Lenti MV, Mengoli C, Pellegrini L, Pieraccini A, Ribaldone D, Testa A, Ubezio C, Viola A, Vecchi M, Klersy C, Di Sabatino A. Prevalence, Pathogenesis and Management of Anemia in Inflammatory Bowel Disease: An IG-IBD Multicenter, Prospective, and Observational Study. Inflamm Bowel Dis. 2023 Jan 5;29(1):76-84. doi: 10.1093/ibd/izac054.

  PMID: 35366312 DERIVED

MeSH Terms

Conditions

Anemia; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 19, 2016
• Study Start: September 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 24, 2020

Record last verified: 2020-09

Locations

IT (1)