NCT05581420: OVI-IBD

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

Status unknown NA Last updated 12 October 2022

What this trial tests

NA trial testing Ferrous fumarate in Inflammatory Bowel Diseases in 152 participants. Status unknown.

Timeline

2 June 2022

Primary endpoint
1 May 2025

1 May 2025

Quick facts

Lead sponsor	Leiden University Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	152
Start date	2 June 2022
Primary completion	1 May 2025
Estimated completion	1 May 2025
Sites	1 location across Netherlands

Drugs / interventions tested

• Ferrous fumarate (FERROUS FUMARATE) — full drug profile →
• MonoFer — full drug profile →

Conditions studied

• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →

Sponsor

Leiden University Medical Center

Who can join

18 and older, any sex, with Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Normalization of Hb concentration (> 7.3 mmol/L (females) or > 8.0 mmol/L (males)) from baseline to week 12 in both oral and iv iron supplementation group.
  Time frame: After 12 weeks
  Percentage of patients who achieved an adequate hematologic response (defined by Hb \> 7.3 mmol/L (females) or \> 8.0 mmol/L (males)) after 12 weeks

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Trial: Predicting Response to Iron Therapy in Patients With Active Inflammatory Bowel Disease Using Hepcidin and Functional Iron Indices: A Multicentre Randomised Trial.
   Koppelman LJM, Loveikyte R, Goetgebuer RL, van der Marel S, et al · · 2026 · PMID 42261111 · DOI 10.1111/apt.70775