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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis

Conditions
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Anemia, Iron Deficiency, Ulcerative Colitis

Intervention / Treatment
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* Drug: Sucrosomial Iron
* Drug: Oral Iron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sucrosomial Iron<br>These patients will receive Sucrosomial Iron 30 mg + 70 mg ascorbic acid (Sideral Forte) twice daily | Drug: Sucrosomial Iron<br>* Experimental Arm<br>* Other names: Sideral Forte;|
| Active Comparator: Oral Iron Therapy<br>These patients will receive Oral Iron therapy at a dose of 195 mg twice daily for the same period of time | Drug: Oral Iron<br>* Active Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of experimental product | Tolerability will be assessed via a Treatment Tolerability Assessment Questionnaire | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to iron repletion | Hemoglobin | 12 weeks | 
| Compliance and adherence | Regular Pill Counts | 12 weeks | 
| Response to iron repletion | Hematocrit | 12 weeks | 
| Response to iron repletion | Iron storage | 12 weeks | 
| Response to iron repletion | Iron saturation | 12 weeks | 
| Response to iron repletion | Ferritin | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sucrosomial Iron, Sideral Forte, Iron Supplementation, Iron Deficiency, Anemia, Ulcerative Colitis, Inflammatory Bowel Disease