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

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Established IBD diagnosis (Crohn's disease, ulcerative colitis, IBD-unclassified)

• Adults (≥18 years of age)

• Any single Hb level between 6,2 - 7,3 mmol/L (females) 6,2 - 8,0 mmol/L (males)

• Any single ferritin \<100 μg/L and transferrin saturation \<20% within 4 weeks of study inclusion

• CRP \> 5 mg/L and / or fecal calprotectin \> 150 within 4 weeks of randomization

• Patients on immunosuppressive medication (thiopurine, methotrexate, biologicals, JAK inhibitor) for at least 8 weeks or if prednisone, for at least 2 weeks

• Mild to moderate disease according to the treating physician; a Physician Global Assessment (PGA) score of 1 or 2

• Documented informed consent

Locations
Other Locations
Netherlands
Leiden University Medical Centre
RECRUITING
Leiden
Contact Information
Primary
L.J.M. Koppelman, Msc.
patientenibd@lumc.nl
0031715297902
Time Frame
Start Date: 2022-06-02
Completion Date: 2025-05
Participants
Target number of participants: 152
Treatments
Active_comparator: Oral iron
Ferrous fumarate 200mg daily for 4 weeks.~Group A1 (Normal Hb at week 4):~Ferrous fumarate 100mg daily for 12 weeks~Group A2 (Abnormal Hb at week 4):~Ferrous fumarate 200mg daily for 8 weeks~Group A2 at week 12:~Normal Hb: ferrous fumarate 100 mg daily till week 16 Abnormal Hb: intervention failure. End of study.
Active_comparator: IV Iron
Dosage based on iron formulation and instructions according to recommended guidelines (weight of patient)
Sponsors
Collaborators: UMC Utrecht, University Medical Center Groningen, Sint Franciscus Gasthuis, Adrz, Goes, Medical Center Haaglanden, Erasmus Medical Center, Rijnstate Hospital
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov