EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD
NCT06321887 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-03-20
Summary
Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD). However, although iron is commonly prescribed, the amount of elemental iron needed to achieve clinical efficacy, and the optimal method of supplementation, are under debate. This pilot study aims to investigate the efficacy and safety of low dose and standard dose oral iron preparations for the treatment of IDA in patients with IBD.
Conditions
Interventions
- DRUG
-
Ferrous fumarate syrup 2.5ml/70mg (22.5mg elemental iron)
Ferrous fumarate syrup 2.5ml/70mg (22.5mg elemental iron) daily for 8 weeks (N=10).
- DRUG
-
Ferrous fumarate syrup 2.5ml/70mg(45mg elemental iron)
Ferrous fumarate syrup 5ml/140mg (45mg elemental iron) daily for 8 weeks (N=10).
- DRUG
-
Ferrous fumarate syrup 2.5ml/70mg (90mg elemental iron)
Ferrous fumarate syrup 5ml/140mg twice daily (90mg elemental iron) for 8 weeks (N=10).
Sponsors & Collaborators
-
Liverpool University Hospitals NHS Foundation Trust
lead OTHER_GOV
Principal Investigators
-
T Conley · Liverpool University Foundation NHS Trust
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-10-20
- Primary Completion
- 2024-10-01
- Completion
- 2025-10-01
Countries
- United Kingdom
Study Locations
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