CompletedPhase 4

Optimizing Dosing Strategies in Oral Iron Supplementation

Switzerland29 participantsStarted 2024-03-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of Hemoglobin after 12 weeks

Timeframe: 12 weeks

Trial details

NCT IDNCT06238895

SponsorLuzerner Kantonsspital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-18

View on ClinicalTrials.gov More Iron Deficiencies trials