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

NCT ID: NCT05225545

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2024-05-04

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.

Conditions

Anemia, Iron Deficiency; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sucrosomial Iron

These patients will receive Sucrosomial Iron 30 mg + 70 mg ascorbic acid (Sideral Forte) twice daily

Group Type: EXPERIMENTAL

Sucrosomial Iron

Intervention Type: DRUG

Experimental Arm

Oral Iron Therapy

These patients will receive Oral Iron therapy at a dose of 195 mg twice daily for the same period of time

Group Type: ACTIVE_COMPARATOR

Oral Iron

Intervention Type: DRUG

Active Comparator

Interventions

Sucrosomial Iron

Experimental Arm

Intervention Type: DRUG

Oral Iron

Active Comparator

Intervention Type: DRUG

Other Intervention Names

Sideral Forte

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharma M SAL, Lebanon

UNKNOWN

Sponsor Role: collaborator

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ala Sharara, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

American University of Beirut - Medical Center

Beirut, , Lebanon

Site Status: RECRUITING

Countries

Lebanon

Central Contacts

Ali El Mokahal, MD

Role: CONTACT

ae136@aub.edu.lb

+961350000 ext. 5909

Facility Contacts

Ala' I. Sharara, MD

Role: primary

as08@aub.edu.lb

009611350000 ext. 5345

References

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.

Reference Type: BACKGROUND

PMID: 15247190 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12368409 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12663492 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24486177 (View on PubMed)

Other Identifiers

BIO-2019-0046:

Identifier Type: -

Identifier Source: org_study_id