A Phase 3 interventional study of Sucrosomial Iron and Oral Iron in Anemia, Iron Deficiency and Ulcerative Colitis, sponsored by American University of Beirut Medical Center. Recruiting at 1 site in Lebanon. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by American University of Beirut Medical Center · Phase 3, Interventional, and Treatment
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →American University of Beirut Medical Center is the lead sponsor of 152 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
These patients will receive Sucrosomial Iron 30 mg + 70 mg ascorbic acid (Sideral Forte) twice daily
Drug: Sucrosomial Iron
These patients will receive Oral Iron therapy at a dose of 195 mg twice daily for the same period of time
Drug: Oral Iron
Experimental Arm
Also known as: Sideral Forte
Active Comparator
Tolerability 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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American University of Beirut Medical Center