Comparing Sucrosomial Iron and Oral Iron for Treating Anemia in Ulcerative Colitis
Randomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis
This study tests if a new type of iron supplement called Sucrosomial Iron works better and is easier to tolerate than regular Oral Iron for adults with anemia caused by Ulcerative Colitis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | American University of Beirut Medical Center Academic / other |
| Locations | 1 site (Beirut) |
| Trial ID | NCT05225545 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the tolerability and efficacy of Sucrosomial Iron compared to Oral Iron Therapy in patients suffering from Iron Deficiency Anemia associated with Ulcerative Colitis. It is a randomized controlled trial that focuses on patients over 18 years old who have been diagnosed with Ulcerative Colitis and have confirmed Iron Deficiency Anemia. The study will assess how well Sucrosomial Iron, a new iron preparation with better absorption and fewer side effects, performs against traditional Oral Iron supplementation, which can exacerbate symptoms in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with a confirmed diagnosis of Ulcerative Colitis and proven Iron Deficiency Anemia.
Not a fit: Patients who may not benefit from this study include those with severe anemia (Hb < 8g/dl), recent disease flare, or known intolerances to oral iron therapy.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with Iron Deficiency Anemia related to Ulcerative Colitis.
How similar studies have performed: Other studies have shown promising results with Sucrosomial Iron in various patient populations, suggesting potential for success in this specific application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beirut
- American University of Beirut - Medical Center — Beirut, Lebanon (Recruiting)
Study contacts
- Principal investigator: Ala Sharara, MD — American University of Beirut Medical Center
- Study coordinator: Ali El Mokahal, MD
- Email: ae136@aub.edu.lb
- Phone: +961350000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.