Back to resultsStudy of the Prevalence of Iron Deficiency in Patients With Chronic Inflammatory Bowel Disease
Primary Purpose
Intestinal Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iron status testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Intestinal Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IBD
Arm Description
Outcomes
Primary Outcome Measures
Ferritinemia according to inflammatory status
Ferritinemia will be assessed from blood sample (iron status)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04123990
Brief Title
Study of the Prevalence of Iron Deficiency in Patients With Chronic Inflammatory Bowel Disease
Official Title
Study of the Prevalence of Iron Deficiency in Patients With Chronic Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2, 2019 (Anticipated)
Primary Completion Date
February 28, 2020 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIFORFRANCE
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 Cacoub (unpublished) on the national health insurance database showed that iron deficiency was an under-diagnosed and under-treated co-morbidity.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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IBD
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Iron status testing
Intervention Description
Iron status testing
Primary Outcome Measure Information:
Title
Ferritinemia according to inflammatory status
Description
Ferritinemia will be assessed from blood sample (iron status)
Time Frame
One day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Prevalence of Iron Deficiency in Patients With Chronic Inflammatory Bowel Disease
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