Optimizing Dosing Strategies in Oral Iron Supplementation (OPTIDOSE)

L

Luzerner Kantonsspital

Status and phase

Enrolling
Phase 4

Conditions

Iron Deficiency Anemia
Iron Deficiencies
Iron Deficiency Anemia Treatment

Treatments

Drug: Tardyferon

Study type

Interventional

Funder types

Other

Identifiers

NCT06238895
2023-02317

Details and patient eligibility

About

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).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Intervention Group
Experimental group
Description:
Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every second day 2 x 80 mg Tardyferon® for a duration of 12 weeks.
Treatment:
Drug: Tardyferon
Active Control
Active Comparator group
Description:
Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every day 1x 80 mg Tardyferon® for a duration of 12 weeks
Treatment:
Drug: Tardyferon

Trial contacts and locations

0

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Central trial contact

Meyer

Data sourced from clinicaltrials.gov

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