NL-OMON54041RecruitingNot Applicable
Predicting Response to Iron Supplementation in Patients with active Inflammatory Bowel Disease - PRIme
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
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 <100
- •ug/l and hemoglobin <7.5 mmol/l for females or <8.5 mmol/l for males) or iron
- •deficiency (defined as ferritin <100 ug/l and transferrin saturation <20%) -
- •Documented informed consent
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 <6.2 mmol/l for females and males) - Documented
- •history of liver cirrhosis, heart failure, hemoglobinopathies, autoimmune
- •hemolytic anemia, myelodysplastic syndrome, or chronic obstructive pulmonary
- •disease (COPD) - Documented history of recent treatment for a malignancy
- •(excluding dermatological malignancies such as basal cell carcinoma or squamous
- •cell carcinoma). Patients can be included if the treatment for malignancy has
- •been finalized >=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
- •<30 ml/min/1.73m2) - Folic acid or vitamin B12 deficiency in combination with a
- •macrocytic anemia (Mean Corpuscular Volume >100 fL + Hb <7.5 mmol/L for females
- •or Hb <8.5 mmol/L for males) - Documented pregnancy or breastfeeding at the
- •time of inclusion - Documented major operation (e.g., laparotomy) less than six
- •weeks before inclusion - Unable to give informed consent due to inability to
- •understand Dutch language or incapacitation (e.g., due to
- •cognitive/psychological conditions or hospitalization in Intensive Care)
Investigators
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