Optimizing Dosing Strategies in Oral Iron Supplementation

Iron Deficiency Anemia Clinical Trial

— OPTIDOSE  

Official title:

Optimizing Dosing Strategies in Oral Iron Supplementation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238895
• Other study ID #: 2023-02317
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: February 2024
• Source: Luzerner Kantonsspital
• Contact: Meyer
• Phone: +41 41 205 11 11
• Email: eisenstudie[@]luks.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia
• Iron Deficiency Anemia Treatment

Intervention

Drug:
• Tardyferon
Interval Dosing Strategy (Administration of oral iron every second day with double the standard dose instead of every day standard dose)

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Hemoglobin after 12 weeks	Change (from baseline before treatment) of hemoglobin after 12 weeks of oral iron supplementation	12 weeks
Secondary	Proportion of participants achieving treatment goal	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	12 weeks
Secondary	Change of iron parameters from baseline	Change of iron parameters from baseline compared to after treatment of 12 weeks	12 weeks
Secondary	Side effects	Side effects during treatment with oral iron supplementation in both groups (intervention and active control)	12 weeks