Randomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis
| Registry | NCT05225545 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | American University of Beirut Medical Center (Other); collaborators: Pharma M SAL, Lebanon |
| Conditions | Anemia, Iron Deficiency, Ulcerative Colitis |
| Interventions | Sucrosomial Iron, Oral Iron (Drug) |
| Dates | start 2019-11-04, primary completion 2024-05-04 (estimated), completion 2024-05-04 (estimated), first posted 2022-02-04, last updated 2024-01-31 |
| Locations | 1 site in Lebanon |
Related Papers Related Patents Related Grants Related Experts
All trials for Anemia, Iron Deficiency All trials for Ulcerative Colitis All trials of Sucrosomial Iron All trials of Oral Iron
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sucrosomial Iron | Experimental | Drug: Sucrosomial Iron | These patients will receive Sucrosomial Iron 30 mg + 70 mg ascorbic acid (Sideral Forte) twice daily |
| Oral Iron Therapy | Active comparator | Drug: Oral Iron | These patients will receive Oral Iron therapy at a dose of 195 mg twice daily for the same period of time |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| American University of Beirut - Medical Center | Beirut | Lebanon | Recruiting |