Oral Versus Intravenous Iron in IBD Patients With Anti-inflammatory Therapy.

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.

Conditions

• Inflammatory Bowel Diseases

Interventions

DRUG

Ferrous fumarate

Patients randomized in the oral group, will all be prescribed ferrous fumarate 200 mg d.d. for the first 4 weeks. Then, depending on their iron status, 100 mg d.d. for the following 12 weeks or 4 more weeks 200 mg d.d. followed by 4 weeks 100 mg d.d.. If iron levels are still too low after 12 weeks, the intervention has failed.

DRUG

MonoFer

Study patients will be treated with intravenous iron. The brand name of the iv iron is dependent on the hospital policy and the doses will be according to recommended guidelines (weight of patient). Iv iron is intramural medication without add-on status and needs infusion at daycare.

Sponsors & Collaborators

• University Medical Center Groningen

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Sint Franciscus Gasthuis

  collaborator OTHER

• Adrz, Goes

  collaborator UNKNOWN

• Medical Center Haaglanden

  collaborator OTHER

• Leiden University Medical Center

  lead OTHER

Principal Investigators

• A.E. van der Meulen - de Jong, MD, PhD · Leiden University Medical Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-02

Primary Completion

2025-05-31

Completion

2025-05-31

Countries

• Netherlands

Study Locations