NCT05456932

Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. Recent illumination of iron metabolism has brought attention to the systemic iron regulator-hepcidin, a peptide hormone that regulates intestinal iron absorption and systemic iron availability. Elevated hepcidin is associated with oral iron malabsorption in IBD. This study aims to evaluate whether hepcidin concentration at baseline can predict response to oral and intravenous iron therapy in patients with IBD and concomitant iron deficiency with or without anemia.

Detailed description

The PRIme is a multicenter and randomized study that aims to evaluate the capacity of hepcidin at baseline to predict response to oral or intravenous iron therapy in patients with active IBD. Study participants will be randomized and allocated (open-label) to one of the three study arms: intravenous iron therapy, therapy with oral ferrous fumarate, or therapy with oral ferric maltol. During the study, biochemical indices such as hemoglobin, iron status, hepcidin and related cytokines will be measured at week 6, 14, and 24 after the start of the therapy. In addition, the study will evaluate changes in oxidative stress, quality of live, and productivity.

Conditions

• Inflammatory Bowel Diseases
• Iron-deficiency
• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Intravenous iron	Included participants will receive intravenous iron therapy, the dosage will be based on national pharmaceutical formulary.
DRUG	Ferric maltol	Included participants will receive oral iron therapy with ferric maltol (twice a day 30mg for 12 weeks)
DRUG	Ferrous fumarate	Included participants will receive oral iron therapy with ferrous fumarate (twice a day 100mg for 12 weeks)

Timeline

• Start date: 2022-08-19
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2022-07-13
• Last updated: 2023-03-31

Locations

5 sites across 1 country: Netherlands