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Optimizing Dosing Strategies in Oral Iron Supplementation

Optimizing Dosing Strategies in Oral Iron Supplementation

Recruiting
18 years and older
All
Phase 4

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Overview

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).

Eligibility

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 details
    Iron Deficiencies
    Iron Deficiency Anemia
    Iron Deficiency Anemia Treatment

NCT06238895

Luzerner Kantonsspital

16 February 2024

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