Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT02774057
Eligibility Criteria:
Inclusion Criteria:
* Age above 18
* Confirmed diagnosis of ulcerative colitis or Crohn's disease
* Proven iron deficiency anemia (Hb\<12, transferrin saturation \<20%)
* Active left sided colitis or extensive disease (Mayo Score≥5 or Partial Mayo score ≥4)
* Hemoglobin level \> 8 g/dL
Exclusion Criteria:
* Age below 18
* Hemoglobin level \< 8 g/dL
* Recently hospitalized for disease flare (within 3 months)
* Hemoglobinopathies (including thalassemia)
* Isolated proctitis
* indeterminate colitis
* Known Liver or kidney disease
* Known Celiac disease
* Small bowel resection
* Use of anticoagulants or aspirin
* Known intolerance to oral iron therapy
* Uninvestigated anemia
* Pregnant or lactating women
* Known hypersensitivity to iron sulfate
* Transfusion within the last 4 weeks
* Erythropoetin within the last 8 weeks
* Rheumatoid Arthritis
* History of menometrorrhagia or frequent epistaxis
* Use of Stomach acid-reducing product (classical antacids, Proton Pump Inhibitors, H2-receptors Inhibitors)
* Gastritis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02774057
Study Brief:
Protocol Section:
NCT02774057