Clinical trial NCT05225545: Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis
Official title: Randomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Anemia, Iron Deficiency
Ulcerative Colitis
Keywords: Sucrosomial Iron
Sideral Forte
Iron Supplementation
Iron Deficiency
Anemia
Ulcerative Colitis
Inflammatory Bowel Disease
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: Pharma M SAL, Lebanon
First posted: 2022-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tolerability of experimental product
timeFrame: 12 weeks
Secondary outcomes:
measure: Response to iron repletion
timeFrame: 12 weeks
measure: Compliance and adherence
timeFrame: 12 weeks
measure: Response to iron repletion
timeFrame: 12 weeks
measure: Response to iron repletion
timeFrame: 12 weeks
measure: Response to iron repletion
timeFrame: 12 weeks
measure: Response to iron repletion
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut - Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Ala Sharara, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.