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

• Status: Recruiting
• Trial end date: 2022-05-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American University of Beirut Medical Center
• Collaborator: Pharma M
• Treatments: Iron

Criteria

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