Status:
UNKNOWN
Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis
Lead Sponsor:
American University of Beirut Medical Center
Collaborating Sponsors:
Pharma M SAL, Lebanon
Conditions:
Anemia, Iron Deficiency
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Col...
Detailed Description
Ulcerative Colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to the mucosal layer of the colon. Anemia is a consistent clinical feature of IBD, and is e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 4 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05225545
Start Date
November 4 2019
End Date
May 4 2024
Last Update
January 31 2024
Active Locations (1)
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1
American University of Beirut - Medical Center
Beirut, Lebanon