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

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 Cacoub (unpublished) on the national health insurance database showed that iron deficiency was an under-diagnosed and under-treated co-morbidity.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)

Study Overview

• Status: Unknown
• Conditions: Intestinal Disease
• Intervention / Treatment: Diagnostic test: Iron status testing

• Study Type: Interventional
• Enrollment (Anticipated): 1100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBD	Diagnostic test: Iron status testing; Iron status testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ferritinemia according to inflammatory status	Ferritinemia will be assessed from blood sample (iron status)	One day

Collaborators and Investigators

• Sponsor: VIFORFRANCE

Study record dates

Study Major Dates

• Study Start (Anticipated): November 2, 2019
• Primary Completion (Anticipated): February 28, 2020
• Study Completion (Anticipated): March 30, 2020

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: CARENFER MICI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No