Iron DeficienciesPhase 4OPTIDOSENCT06238895
Optimizing Dosing Strategies in Oral Iron Supplementation
A Phase 4 study testing Tardyferon in people with Iron Deficiencies and Iron Deficiency Anemia, run by Luzerner Kantonsspital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiencies, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment
- What is being tested?
- Tardyferon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2024to 18 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent signed by the subject
- ≥18 years of age
- Iron deficiency: Ferritin <30 µg/l
- hemoglobin ≥ 80 g/l
- CRP < 5 mg/l
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Being tested
- Tardyferon
- Keywords
- iron deficiency anemia, oral iron supplementation, iron supplementation, gender differences
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TardyferonDrug
Interval Dosing Strategy (Administration of oral iron every second day with double the standard dose instead of every day standard dose)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every second day 2 x 80 mg Tardyferon® for a duration of 12 weeks. Receives: Drug: Tardyferon |
| Active Control | Active comparator | Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every day 1x 80 mg Tardyferon® for a duration of 12 weeks Receives: Drug: Tardyferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Hemoglobin after 12 weeks
Change (from baseline before treatment) of hemoglobin after 12 weeks of oral iron supplementation
Measured: 12 weeks
Secondary outcomes (3)
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
Measured: 12 weeks
Change of iron parameters from baseline
Change of iron parameters from baseline compared to after treatment of 12 weeks
Measured: 12 weeks
Side effects
Side effects during treatment with oral iron supplementation in both groups (intervention and active control)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Mar 2024
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Meyer, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238895
- Sponsor's protocol ID
- 2023-02317
- Other IDs
- 2023
- Acronym
- OPTIDOSE
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Dosing Strategies in Oral Iron Supplementation
- ClinicalTrials.gov ID
- NCT06238895
- Acronym / sponsor ID
- OPTIDOSE / 2023-02317
- Keywords
- iron deficiency anemia, oral iron supplementation, iron supplementation, gender differences
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: TardyferonOral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every second day 2 x 80 mg Tardyferon® for a duration of 12 weeks. |
| Active Control | Active comparator | Drug: TardyferonOral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every day 1x 80 mg Tardyferon® for a duration of 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent signed by the subject
- ≥18 years of age
- Iron deficiency: Ferritin <30 µg/l
- hemoglobin ≥ 80 g/l
- CRP < 5 mg/l
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TardyferonInterval Dosing Strategy (Administration of oral iron every second day with double the standard dose instead of every day standard dose) | Drug | Active Control, Intervention Group |
Primary outcome
Change of Hemoglobin after 12 weeks
Time frame: 12 weeks
Change (from baseline before treatment) of hemoglobin after 12 weeks of oral iron supplementation
3 secondary outcomes
Proportion of participants achieving treatment goal
Time frame: 12 weeks
Change of iron parameters from baseline
Time frame: 12 weeks
Side effects
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tardyferon in people with Iron Deficiencies and Iron Deficiency Anemia, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Hemoglobin after 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.