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

Inflammatory Bowel Diseases Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05456932
• Study type: Interventional
• Source: Leiden University Medical Center
• Contact: R. Loveikyte, MD
• Phone: 00315297902
• Email: patientenibd@lumc.nl
• Status: Recruiting
• Phase: Phase 4
• Start date: August 19, 2022
• Completion date: August 31, 2023