Randomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis

BIO-2019-0046:

The aim of the study is to compare the tolerability and efficacy of Sucrosomial Iron to Oral Iron Therapy in a randomized controlled trial for the treatment of Iron Deficiency Anemia in Ulcerative Colitis patients.

2019-11-04

2024-05-04

2024-05-04

Recruiting

Early phase I

30

Inclusion Criteria: * Age above 18 * Confirmed diagnosis of Ulcerative Colitis * Proven Iron Deficiency Anemia (Hb \< 12 for females and Hb \< 13 for males AND iron saturation \<20%) * Hemoglobin level \> 8g/dl Exclusion Criteria: * Age below 18 * Hemoglobin level \< 8g/dl * Recently hospitalized for disease flare (within 3 months) * Hemoglobinopathies (including thalassemia) * Isolated proctitis * Indeterminate colitis * Known liver or kidney disease * Known Celiac Disease * Extensive 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 in the past 4 weeks * Erythropoetin within the last 8 weeks * Rheumatoid Arthritis * History of menometrorrhagia or frequent epistaxis

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-01-31