NCT05225545

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2024

Completed
Last Updated

January 31, 2024

Status Verified

December 1, 2023

Enrollment Period

4.5 years

First QC Date

October 9, 2020

Last Update Submit

January 30, 2024

Conditions

Anemia, Iron DeficiencyUlcerative Colitis

Keywords

Sucrosomial IronSideral ForteIron SupplementationIron DeficiencyAnemiaUlcerative ColitisInflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Tolerability of experimental product

    Tolerability will be assessed via a Treatment Tolerability Assessment Questionnaire

    12 weeks

Secondary Outcomes (6)

  • Response to iron repletion

    12 weeks

  • Compliance and adherence

    12 weeks

  • Response to iron repletion

    12 weeks

  • Response to iron repletion

    12 weeks

  • Response to iron repletion

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

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

Sucrosomial IronDRUG

Experimental Arm

Also known as: Sideral Forte
Sucrosomial Iron
Oral IronDRUG

Active Comparator

Oral Iron Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut - Medical Center

Beirut, Lebanon

RECRUITING

Related Publications (4)

  • 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.

    PMID: 15247190BACKGROUND

  • 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.

    PMID: 12368409BACKGROUND

  • 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.

    PMID: 12663492BACKGROUND

  • 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.

    PMID: 24486177BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-DeficiencyColitis, UlcerativeIron DeficienciesAnemiaInflammatory Bowel Diseases

Interventions

sucrosomial ironIron

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Ala Sharara, MD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali El Mokahal, MD

CONTACT

+961350000ae136@aub.edu.lb

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2020

First Posted

February 4, 2022

Study Start

November 4, 2019

Primary Completion

May 4, 2024

Study Completion

May 4, 2024

Last Updated

January 31, 2024

Record last verified: 2023-12

Locations

LE(1)