Study of the Prevalence of Iron Deficiency in Patients With Chronic Inflammatory Bowel Disease

NCT04123990 | Unknown

• 1 other identifier: CARENFER MICI
• Study Type: interventional
• Target: 1,100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite its known prevalence in IBD, a recent study conducted with Prof. Cacoub (unpublished) on the national health insurance database showed that iron deficiency was an under-diagnosed and under-treated co-morbidity. In chronic diseases including IBD, Transferrin Saturation Factor is only performed in approximately 10% of cases, whereas it is recommended in inflammatory situations including IBD patients (HAS 2011). The objective of this study is therefore to obtain updated French data on the prevalence of iron deficiency in patients with IBD by applying the recommendations of ECCO and French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor)

Conditions

Intestinal Disease

Outcome Measures

Primary Outcomes (1)

• Ferritinemia according to inflammatory status

  Ferritinemia will be assessed from blood sample (iron status)

  One day

Study Arms (1)

IBD

EXPERIMENTAL

Diagnostic Test: Iron status testing

Interventions

Iron status testing DIAGNOSTIC_TEST

Iron status testing

IBD

Eligibility Criteria

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

You may qualify if:

• Patient, male or female, over 18 years old
• Patient present at the hospital on the day of the study
• Diagnosis of IBD on international criteria
• Patient giving written consent

You may not qualify if:

• Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
• pregnant, lactating or parturient woman;
• Patient hospitalized without consent

Sponsors & Collaborators

• VIFORFRANCE: lead

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: November 2, 2019
• Primary Completion: February 28, 2020
• Study Completion: March 30, 2020
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share