Optimizing Dosing Strategies in Oral Iron Supplementation

Phase 4

Recruiting

• Conditions: Iron Deficiency Anemia; Iron Deficiencies; Iron Deficiency Anemia Treatment
• Interventions: Drug: Tardyferon

• Registration Number: NCT06238895
• Lead Sponsor: Luzerner Kantonsspital

Brief Summary

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.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-25
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-02
• Study Start: 2024-03-01
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2025-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Informed Consent signed by the subject
• ≥18 years of age
• Iron deficiency: Ferritin <30 µg/l
• hemoglobin ≥ 80 g/l
• CRP < 5 mg/l

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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.

Note

Due to slow recruitment, the following inclusion criterion was removed on 09/25/2024 (MM/DD/YYYY):

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change of Hemoglobin after 12 weeks	12 weeks	Change (from baseline before treatment) of hemoglobin after 12 weeks of oral iron supplementation

Secondary Outcome Measures

Name	Time	Method
Proportion of participants achieving treatment goal	12 weeks	Proportion of participants achieving either increase of hemoglobin (\>20 g/l), normalization of hemoglobin (women \>120 g/l, pregnant women \>110 g/l and men \>130 g/l) after 12 weeks of oral iron supplementation
Change of iron parameters from baseline	12 weeks	Change of iron parameters from baseline compared to after treatment of 12 weeks
Side effects	12 weeks	Side effects during treatment with oral iron supplementation in both groups (intervention and active control)

Trial Locations

Locations (1)

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland