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

Intestinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04123990
• Other study ID #: CARENFER MICI
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: October 2019
• Source: VIFORFRANCE
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 Cacoub (unpublished) on the national health insurance database showed that iron deficiency was an under-diagnosed and under-treated co-morbidity.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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1100
• Est. completion date: March 30, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Disease
• Intestinal Diseases

Intervention

Diagnostic Test:
• Iron status testing
Iron status testing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VIFORFRANCE

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ferritinemia according to inflammatory status	Ferritinemia will be assessed from blood sample (iron status)	One day