Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment... | NCT05225545

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

NCT05225545

Sponsor

American University of Beirut Medical Center

Status

Unknown status

Last Update Posted

Jan 31, 2024Actual

Enrollment

30Estimated

Phase

Phase 3

Conditions

Anemia, Iron Deficiency
Ulcerative Colitis

Interventions

Sucrosomial Iron
Oral Iron

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2019Actual

Primary Completion Date

May 4, 2024Estimated

Completion Date

May 4, 2024Estimated

First Submitted Date

Oct 9, 2020

First Submission Date that Met QC Criteria

Feb 1, 2022

First Posted Date

Feb 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2024

Last Update Posted Date

Jan 31, 2024Actual

Name	Class
Pharma M SAL, Lebanon	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sucrosomial Iron	Experimental	These patients will receive Sucrosomial Iron 30 mg + 70 mg ascorbic acid (Sideral Forte) twice daily	Drug: Sucrosomial Iron
Oral Iron Therapy	Active Comparator	These patients will receive Oral Iron therapy at a dose of 195 mg twice daily for the same period of time	Drug: Oral Iron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sucrosomial Iron	Drug	Experimental Arm	Sucrosomial Iron	Sideral Forte

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Response to iron repletion	Hemoglobin	12 weeks
Compliance and adherence	Regular Pill Counts	12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ali El Mokahal, MD	Contact	+961350000	5909	ae136@aub.edu.lb

Overall Officials

Name	Affiliation	Role
Ala Sharara, MD	American University of Beirut Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
American University of Beirut - Medical Center	Recruiting	Beirut			Lebanon

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15247190	Background	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.
12368409	Background	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.

ID	Term
D018798	Anemia, Iron-Deficiency
D003093	Colitis, Ulcerative
D000090463	Iron Deficiencies
D000740	Anemia
D015212	Inflammatory Bowel Diseases

ID	Term
D000747	Anemia, Hypochromic
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D019189	Iron Metabolism Disorders

ID	Term
C000718012	sucrosomial iron
D007501	Iron

ID	Term
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D028561	Transition Elements