Optimizing Dosing Strategies in Oral Iron Supplementation

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Description

The goal of this clinical trial is to evaluate, if a change in dosing strategy in oral iron supplementation from leads to an improvement of iron absorption and consequently a faster therapy in patients with iron deficiency anemia.

The main question the study aims to answer is: Does a treatment effect (measured by change in hemoglobin after 12 weeks of treatment) exist between daily oral iron supplementation and interval administration (every second day)? Participants will receive oral iron supplementation every second day with double the standard dose (intervention group). Researchers will compare this group with the active control group, that receives oral iron supplementation every day with the standard dose.

Participants will present for three patient visits (at baseline, after 6 and after 12 weeks of treatment).

Study Overview

Start Date
March 1, 2024
Completion Date
March 31, 2026
Enrollment
100
Date Posted
February 2, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Luzerner Kantonsspital
Luzern, Switzerland

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Informed Consent signed by the subject
≥18 years of age
Anemia (as defined by the WHO): Hemoglobin <130 g/L for men, Hemoglobin <120 g/l for women, Hemoglobin <110 g/l for pregnant women
Iron deficiency: Ferritin <30 µg/l
hemoglobin ≥ 80 g/l
CRP < 5 mg/l

Exclusion Criteria:

Refusal of study participation,
Regular administration of Erythropoietin
Oral or intravenous iron supplementation <12 weeks prior to investigation
Contraindications to intervention medication (Tardyferon), e.g. known hypersensitivity or allergy to iron sulfate / ferrous sulfate
Blood transfusion or donation <12 weeks prior to investigation
Active chemotherapy
Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject.

Study Contact Info

Study Contact Name
Meyer
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06238895