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

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

• University Medical Center Groningen

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Leiden University Medical Center

  lead OTHER

Principal Investigators

• A.E. van der Meulen - de Jong, MD, PhD · LUMC

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-19

Primary Completion

2023-08-31

Completion

2023-08-31

Countries

• Netherlands

Study Locations