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

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis; Anemia, Iron Deficiency
• Intervention / Treatment: Drug: Sucrosomial Iron; Drug: Oral Iron

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ali El Mokahal, MD; Phone Number: 5909 +961350000; Email: ae136@aub.edu.lb

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • American University of Beirut - Medical Center
    • Contact: Ala' I. Sharara, MD; Phone Number: 5345 009611350000; Email: as08@aub.edu.lb
    • Principal Investigator: Ala' I Sharara, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sucrosomial Iron; These patients will receive Sucrosomial Iron 30 mg + 70 mg ascorbic acid (Sideral Forte) twice daily	Drug: Sucrosomial Iron; Experimental Arm; Other Names: Sideral Forte
Active Comparator: Oral Iron Therapy; These patients will receive Oral Iron therapy at a dose of 195 mg twice daily for the same period of time	Drug: Oral Iron; Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of experimental product	Tolerability will be assessed via a Treatment Tolerability Assessment Questionnaire	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to iron repletion	Hemoglobin	12 weeks
Compliance and adherence	Regular Pill Counts	12 weeks
Response to iron repletion	Hematocrit	12 weeks
Response to iron repletion	Iron storage	12 weeks
Response to iron repletion	Iron saturation	12 weeks
Response to iron repletion	Ferritin	12 weeks

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Collaborators: Pharma M SAL, Lebanon
• Investigators: Principal Investigator: Ala Sharara, MD, American University of Beirut Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Estimated): May 4, 2024
• Study Completion (Estimated): May 4, 2024

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Anemia; Ulcerative Colitis; Inflammatory Bowel Disease; Iron Deficiency; Iron Supplementation; Sucrosomial Iron; Sideral Forte
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Inflammatory Bowel Diseases; Ulcer; Anemia, Iron-Deficiency; Anemia; Colitis; Colitis, Ulcerative; Iron Deficiencies; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: BIO-2019-0046:

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No