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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Experimental Arm
Active Comparator
American University of Beirut - Medical Center
Beirut, Lebanon
RECRUITINGTolerability of experimental product
Tolerability will be assessed via a Treatment Tolerability Assessment Questionnaire
Time frame: 12 weeks
Response to iron repletion
Hemoglobin
Time frame: 12 weeks
Compliance and adherence
Regular Pill Counts
Time frame: 12 weeks
Response to iron repletion
Hematocrit
Time frame: 12 weeks
Response to iron repletion
Iron storage
Time frame: 12 weeks
Response to iron repletion
Iron saturation
Time frame: 12 weeks
Response to iron repletion
Ferritin
Time frame: 12 weeks
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