Iron Deficiencies, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment
Conditions
Keywords
iron deficiency anemia, oral iron supplementation, iron supplementation, gender differences
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).
Interventions
DRUGTardyferon
Interval Dosing Strategy (Administration of oral iron every second day with double the standard dose instead of every day standard dose)
Sponsors
Luzerner Kantonsspital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Hemoglobin after 12 weeks | 12 weeks | Change (from baseline before treatment) of hemoglobin after 12 weeks of oral iron supplementation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Switzerland
Outcome results
None listed