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Search / Trial NCT05225545

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

Launched by AMERICAN UNIVERSITY OF BEIRUT MEDICAL CENTER · Feb 1, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Sucrosomial Iron Sideral Forte Iron Supplementation Iron Deficiency Anemia Ulcerative Colitis Inflammatory Bowel Disease

ClinConnect Summary

This clinical trial is studying the effectiveness and tolerability of Sucrosomial Iron compared to traditional Oral Iron Sulfate for treating Iron Deficiency Anemia in patients with Ulcerative Colitis. Iron Deficiency Anemia is a condition where your body doesn’t have enough iron, which can lead to fatigue and weakness. The trial aims to find out which iron treatment works better and is easier for patients to take.

To be eligible for this trial, participants must be adults over 18 years old who have been diagnosed with Ulcerative Colitis and have confirmed Iron Deficiency Anemia. This means their hemoglobin levels (a measure of red blood cells) should be above 8 grams per deciliter, but below 12 for women and below 13 for men. Participants can expect regular check-ins and assessments during the trial to monitor their health and response to the treatments. It’s important to know that certain conditions, such as severe anemia, recent hospitalizations, or specific health issues, may prevent someone from participating.

Gender

ALL

Eligibility 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

About American University Of Beirut Medical Center

The American University of Beirut Medical Center (AUBMC) is a leading academic medical institution in the Middle East, dedicated to advancing healthcare through innovative research, education, and clinical excellence. As a prominent sponsor of clinical trials, AUBMC integrates cutting-edge scientific inquiry with patient-centered care to enhance therapeutic options and improve health outcomes. With a commitment to ethical standards and regulatory compliance, AUBMC collaborates with multidisciplinary teams to conduct rigorous trials that contribute to the global medical knowledge base and address critical health challenges in the region and beyond.

Locations

Beirut, , Lebanon

Patients applied

0 patients applied

Trial Officials

Ala Sharara, MD

Principal Investigator

American University of Beirut Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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