Optimizing Dosing Strategies in Oral Iron Supplementation (OPTIDOSE)
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).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Lucerne, Switzerland
- Luzerner Kantonsspital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every second day 2 x 80 mg Tardyferon® for a duration of 12 weeks.
|
Interval Dosing Strategy (Administration of oral iron every second day with double the standard dose instead of every day standard dose)
|
|
Active Comparator: Active Control
Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every day 1x 80 mg Tardyferon® for a duration of 12 weeks
|
Interval Dosing Strategy (Administration of oral iron every second day with double the standard dose instead of every day standard dose)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Hemoglobin after 12 weeks
Time Frame: 12 weeks
|
Change (from baseline before treatment) of hemoglobin after 12 weeks of oral iron supplementation
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of participants achieving treatment goal
Time Frame: 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
|
12 weeks
|
|
Change of iron parameters from baseline
Time Frame: 12 weeks
|
Change of iron parameters from baseline compared to after treatment of 12 weeks
|
12 weeks
|
|
Side effects
Time Frame: 12 weeks
|
Side effects during treatment with oral iron supplementation in both groups (intervention and active control)
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-02317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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