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

Phase 3

Recruiting

• Conditions: Ulcerative Colitis; Anemia, Iron Deficiency
• Interventions: Drug: Sucrosomial Iron; Drug: Oral Iron

• Registration Number: NCT05225545
• Lead Sponsor: American University of Beirut Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-11-04
• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-04
• Status Verified: 2023-12
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31
• Primary Completion: 2024-05-04
• Study Completion: 2024-05-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sucrosomial Iron	Sucrosomial Iron	These patients will receive Sucrosomial Iron 30 mg + 70 mg ascorbic acid (Sideral Forte) twice daily
Oral Iron Therapy	Oral Iron	These patients will receive Oral Iron therapy at a dose of 195 mg twice daily for the same period of time

Primary Outcome Measures

Name	Time	Method
Tolerability of experimental product	12 weeks	Tolerability will be assessed via a Treatment Tolerability Assessment Questionnaire

Secondary Outcome Measures

Name	Time	Method
Response to iron repletion	12 weeks	Ferritin
Compliance and adherence	12 weeks	Regular Pill Counts

Trial Locations

Locations (1)

American University of Beirut - Medical Center; 🇱🇧 Beirut, Lebanon