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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05225545
• Other study ID #: BIO-2019-0046:
• Status: Recruiting
• Phase: Phase 3
• Start date: November 4, 2019
• Est. completion date: May 4, 2024

Study information

• Verified date: December 2023
• Source: American University of Beirut Medical Center
• Contact: Ali El Mokahal, MD
• Phone: +961350000
• Email: ae136[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 4, 2024
• Est. primary completion date: May 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Sucrosomial Iron
Experimental Arm
• Oral Iron
Active Comparator

Locations

Country	Name	City	State
Lebanon	American University of Beirut - Medical Center	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	Pharma M SAL, Lebanon

Country where clinical trial is conducted

Lebanon, 

References & Publications (4)

Carrier J, Aghdassi E, Cullen J, Allard JP. Iron supplementation increases disease activity and vitamin E ameliorates the effect in rats with dextran sulfate sodium-induced colitis. J Nutr. 2002 Oct;132(10):3146-50. doi: 10.1093/jn/131.10.3146. — View Citation

Gasche C, Lomer MC, Cavill I, Weiss G. Iron, anaemia, and inflammatory bowel diseases. Gut. 2004 Aug;53(8):1190-7. doi: 10.1136/gut.2003.035758. — View Citation

Lugg S, Beal F, Nightingale P, Bhala N, Iqbal T. Iron treatment and inflammatory bowel disease: what happens in real practice? J Crohns Colitis. 2014 Aug;8(8):876-80. doi: 10.1016/j.crohns.2014.01.011. Epub 2014 Jan 31. — View Citation

Seril DN, Liao J, Yang GY, Yang CS. Oxidative stress and ulcerative colitis-associated carcinogenesis: studies in humans and animal models. Carcinogenesis. 2003 Mar;24(3):353-62. doi: 10.1093/carcin/24.3.353. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of experimental product	Tolerability will be assessed via a Treatment Tolerability Assessment Questionnaire	12 weeks
Secondary	Response to iron repletion	Hemoglobin	12 weeks
Secondary	Compliance and adherence	Regular Pill Counts	12 weeks
Secondary	Response to iron repletion	Hematocrit	12 weeks
Secondary	Response to iron repletion	Iron storage	12 weeks
Secondary	Response to iron repletion	Iron saturation	12 weeks
Secondary	Response to iron repletion	Ferritin	12 weeks