Overview
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.
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 encountered in one third of patients [1] and Anemia in Ulcerative Colitis is most commonly the result of iron-deficiency due to chronic blood loss through ulcerations in the colon.
Oral Iron supplementation has been used for the treatment of Iron Deficiency anemia but may cause disease exacerbation in patients with UC [2]. Iron also can increase cancer risk [3], and is associated with many side effects such as constipation, diarrhea, nausea, vomiting, abdominal pain and hyperchromia of feces. Furthermore, studies have shown that oral iron supplementation fails to resolve anemia in 2 of 3 IBD patients. [4]
Sucrosomial iron is a new preparation of iron pyrophosphate delivered within a phospholipid membrane and coated with sucrester (sucrose esters of fatty acids). it has been shown to have better absorption and higher bioavailability while minimizing side effects in multiple patient populations.
Eligibility
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