Anemia Clinical Trial
— RIDART-1Official title:
Clinical Burden of Anemia in Inflammatory Bowel Disease: Role of Iron Deficiency And Iron Replacement Therapy, Observational Study (RIDART-1)
Verified date | September 2020 |
Source | IRCCS Policlinico S. Matteo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 740 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Have given written informed consent to participate - Be aged 18 years and over - Have IBD and anemia Exclusion Criteria: - IBD patients without anemia |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Policlinico San Matteo | Pavia |
Lead Sponsor | Collaborator |
---|---|
IRCCS Policlinico S. Matteo |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Ratio between the number of patients with IDA or with AI over the total number of anemic patients | Relative prevalence of IDA and AI in IBD will be computed as the ratio between the number of patients with IDA or with AI over the total number of anemic patients | 12 months | |
Secondary | IBDQ | Influence of anemia on quality of life among IBD patients | 12 months | |
Secondary | Number of hospitalizations in anemic patients | Influence of anemia on hospitalization rate | 12 months |
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