Oral Versus Intravenous Iron in IBD Patients With Anti-inflammatory Therapy.
Status:
Recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
Summary
Rationale: Iron deficiency anemia is the most common systemic manifestation of Inflammatory
Bowel Diseases (IBD)-Crohn's disease and ulcerative colitis. Iron deficiency with or without
anemia poses a diagnostic and therapeutic challenge due to chronic gastrointestinal blood
loss and the inflammatory nature of IBD. Oral iron supplementation in active disease states
is controversial. Hepcidin levels can be considered as the sum effect of all regulatory
processes. Studies suggested that iron stores and hypoxia reduce hepcidin levels even in an
inflammatory state. This is also reflected by a study which demonstrated low levels of
hepcidin in patients with ferritin levels under 30μg/ml, regardless of disease activity or
type. Furthermore, studies show that immunosuppressive medication decrease the level of
hepcidin. This raises the question: is oral iron a viable alternative for patients under
immunosuppressive treatment for active IBD? Objective: The hypothesis is that patients with
mild to moderate IBD activity on immunosuppressive medication, show the same level of Hb
increase after 12 weeks after either oral or iv iron supplementation, while the price of oral
iron supplementation is significantly lower.
Phase:
N/A
Details
Lead Sponsor:
Leiden University Medical Center
Collaborators:
Adrz, Goes Erasmus Medical Center Medical Center Haaglanden Rijnstate Hospital Sint Franciscus Gasthuis UMC Utrecht University Medical Center Groningen