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

American University of Beirut Medical Center

Status and phase: Enrolling; Phase 3

Conditions: Anemia, Iron Deficiency; Ulcerative Colitis

Treatments: Drug: Sucrosomial Iron; Drug: Oral Iron

Study type: Interventional

Funder types: Other

Identifiers

NCT05225545

BIO-2019-0046:

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Sucrosomial Iron

Experimental group

Description:

These patients will receive Sucrosomial Iron 30 mg + 70 mg ascorbic acid (Sideral Forte) twice daily

Treatment:

Drug: Sucrosomial Iron

Oral Iron Therapy

Active Comparator group

Description:

These patients will receive Oral Iron therapy at a dose of 195 mg twice daily for the same period of time

Treatment:

Drug: Oral Iron