Predicting Response to Iron Supplementation in Patients with active Inflammatory Bowel Disease

Predicting Response to Iron Supplementation in Patients with active Inflammatory Bowel Disease - PRIme

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54041

Enrollment

Registered

2022-03-21

Start date

2022-06-08

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD Inflammatory Bowel Disease

Interventions

A. Ferrous fumarate 2dd 100mg p.o. for 12 weeks B. Ferric maltol 2dd 30mg p.o. for 12 weeks C. Intravenous iron: dosage based on instructions on the national formulary 'Farmacotherapeutisch Kompas'

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Established IBD diagnosis (Crohn's disease, ulcerative colitis, IBD-unclassified) - Adults (>=18 years of age) - Active IBD (defined as biochemical activity CRP >5 mg/L and/or FCP >150 mg/kg or as any endoscopic or radiologic disease activity) - Iron deficiency anemia (defined as ferritin

Exclusion criteria

Exclusion criteria: - Blood transfusion or therapy with oral and/or intravenous iron in the past eight weeks - Documented intolerance to oral or intravenous iron - Severe anemia (defined as hemoglobin =6 months before the inclusion date. - Documented history of bariatric surgery or gastric/duodenal resections due to benign or malignant pathologies - End-stage renal disease (impaired renal function, defined as eGFR 100 fL + Hb

Design outcomes

Primary

Measure	Time frame
Whether hepcidin levels at baseline can predict response to iron therapy with either ferrous fumarate, ferric maltol, or intravenous iron (main parameters: hepcidin at baseline, binary response (yes / no) to iron therapy. The response to iron therapy is defined as an increase >1.2 mmol/l in hemoglobin or hemoglobin normalization at week 14 for patients with iron deficiency anemia; or an increase in ferritin >100 µg/l) and transferrin saturation >20% at week 14 for patients with iron deficiency without anemia)	—

Measure

Time frame

Whether hepcidin levels at baseline can predict response to iron therapy with either ferrous fumarate, ferric maltol, or intravenous iron (main parameters: hepcidin at baseline, binary response (yes / no) to iron therapy. The response to iron therapy is defined as an increase >1.2 mmol/l in hemoglobin or hemoglobin normalization at week 14 for patients with iron deficiency anemia; or an increase in ferritin >100 µg/l) and transferrin saturation >20% at week 14 for patients with iron deficiency without anemia)

—

Secondary

Measure	Time frame
- Changes in quality of life (SF-36) - Changes in IBD disease activity (mHI) - Changes in (work) activity impairment (WPAI) - Changes in hypoxie- or inflammatiion-associated biomarkers, oxidative stress, microbiome - Hypophosphatemia and other side effects	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)