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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05225545
Enrollment
30
Registered
2022-02-04
Start date
2019-11-04
Completion date
2024-05-04
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Iron Deficiency, Ulcerative Colitis

Keywords

Sucrosomial Iron, Sideral Forte, Iron Supplementation, Iron Deficiency, Anemia, Ulcerative Colitis, Inflammatory Bowel Disease

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.

Interventions

Experimental Arm

Active Comparator

Sponsors

Pharma M SAL, Lebanon
CollaboratorUNKNOWN
American University of Beirut Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tolerability of experimental product12 weeksTolerability will be assessed via a Treatment Tolerability Assessment Questionnaire

Secondary

MeasureTime frameDescription
Response to iron repletion12 weeksHemoglobin
Compliance and adherence12 weeksRegular Pill Counts

Countries

Lebanon

Contacts

Primary ContactAli El Mokahal, MD
ae136@aub.edu.lb+961350000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026