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

Last updated: January 30, 2024
Sponsor: American University of Beirut Medical Center
Overall Status: Active - Recruiting

Phase

3

Condition

Anemia

Ulcerative Colitis

Colic

Treatment

Sucrosomial Iron

Oral Iron

Clinical Study ID

NCT05225545
BIO-2019-0046:
  • Ages > 18
  • All Genders

Study 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 Colitis patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age above 18
  • Confirmed diagnosis of Ulcerative Colitis
  • Proven Iron Deficiency Anemia (Hb < 12 for females and Hb < 13 for males AND ironsaturation <20%)
  • Hemoglobin level > 8g/dl

Exclusion

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

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Sucrosomial Iron
Phase: 3
Study Start date:
November 04, 2019
Estimated Completion Date:
May 04, 2024

Study 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.

Connect with a study center

  • American University of Beirut - Medical Center

    Beirut,
    Lebanon

    Active - Recruiting

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