Iron Deficiency (Without Anemia)NCT06657677
Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses
A study testing 40mg oral iron dosing, 100mg oral iron dosing and 180mg oral iron dosing in people with Iron Deficiency (Without Anemia), run by Jessica Rigutto at 2 sites in Switzerland.
Trial summary
Serum ferritin is a key indicator of body iron stores and is widely used in monitoring iron status. However, oral iron doses can acutely elevate SF levels, potentially biasing assessments of iron stores during supplementation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency (Without Anemia)
- What is being tested?
- 40mg oral iron dosing, 100mg oral iron dosing and 180mg oral iron dosing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 25 Oct 2024to 16 Dec 2024
- Phase
- Interventional
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Low iron stores (SF levels < 30 µg/L),
- no anemia (Hb > 120 g/L)
- no inflammation (CRP < 5 mg/L)
- 18 to 45 years old.
- Body weight <70 kg
- Normal body Mass Index (18.5-26.5 kg/m2)
Who cannot join
- Any chronic or acute disease
- Consumption of mineral and vitamin supplements since screening and over the study period
- Blood transfusion, blood donation or significant blood loss over the past 6 months,
- Pregnant or breastfeeding,
- Continuous/long-term use of medication during the whole studies (except for contraceptives)
- Therapeutic iron infusion over the past 6 months,
- Known hypersensitivity or allergy to iron supplements,
- Intention to become pregnant over the course of the study
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
ETH Zurich
Zurich, Canton of Zurich, 8092
Laboratory of Nutrition and Metabolic Epigenetics
Zurich, Canton of Zurich, 8092
About this study
Official title: Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women.
Serum ferritin is a key indicator of body iron stores and is widely used in monitoring iron status. However, oral iron doses can acutely elevate SF levels, potentially biasing assessments of iron stores during supplementation. This study aims to investigate the extent and duration of the acute iron-induced effect on serum ferritin, as well as its protein characteristics, following the administration of a single iron dose
- Conditions
- Iron Deficiency (Without Anemia)
- Being tested
- 40mg oral iron dosing, 100mg oral iron dosing, 180mg oral iron dosing
- Keywords
- oral iron supplementation, serum ferritin
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40mg oral iron dosingDietary supplement
Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate
100mg oral iron dosingDietary supplement
Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate
180mg oral iron dosingDietary supplement
Participants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate
| Study group | Role | What they receive |
|---|---|---|
| 40 mg | Experimental | single dose of 40 mg oral iron Receives: Dietary Supplement: 40mg oral iron dosing |
| 100 mg | Experimental | single dose of 100 mg oral iron Receives: Dietary Supplement: 100mg oral iron dosing |
| 180 mg | Experimental | single dose of 180 mg oral iron Receives: Dietary Supplement: 180mg oral iron dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ferritin
Serum ferritin concentration
Measured: study day 1
Serum ferritin
Serum ferritin concentration
Measured: study day 7
Secondary outcomes (27)
C-reactive protein
C-reactive protein concentration in serum
Measured: study day 0
Serum ferritin
Serum ferritin concentration
Measured: study day 0
Serum ferritin
Serum ferritin concentration
Measured: study day 6
Serum ferritin
Serum ferritin concentration
Measured: study day 14
Serum ferritin
Serum ferritin concentration
Measured: study day 5
Serum ferritin
Serum ferritin concentration
Measured: study day 4
Serum ferritin
Serum ferritin concentration
Measured: study day 3
Serum ferritin
Serum ferritin concentration
Measured: study day 2
alpha(1)-acid-glycoprotein
alpha(1)-acid-glycoprotein concentration in serum
Measured: study day 0
soluble transferrin receptor
soluble transferrin receptor in serum
Measured: study day 0
Hemoglobin
Hemoglobin concentration
Measured: study day 0
Serum iron
serum iron concentration in circulation
Measured: study day 0
Serum iron
serum iron concentration in circulation
Measured: study day 1
Serum iron
serum iron concentration in circulation
Measured: study day 2
Serum iron
serum iron concentration in circulation
Measured: study day 3
Serum iron
serum iron concentration in circulation
Measured: study day 4
Serum iron
serum iron concentration in circulation
Measured: study day 5
Serum iron
serum iron concentration in circulation
Measured: study day 6
Serum iron
serum iron concentration in circulation
Measured: study day 7
Serum iron
serum iron concentration in circulation
Measured: study day 14
Isotopic composition of Serum Ferritin
shift in stable iron isotopes in serum ferritin
Measured: study day 0
Isotopic composition of Serum Ferritin
shift in stable iron isotopes in serum ferritin
Measured: study day 2
Isotopic composition of Serum Ferritin
shift in stable iron isotopes in serum ferritin
Measured: study day 7
Structural characteristics of Serum Ferritin
Proteomics
Measured: study day 0
Structural characteristics of Serum Ferritin
Proteomics
Measured: study day 2
Structural characteristics of Serum Ferritin
Proteomics
Measured: study day 7
Fractional iron absorption
Erythrocyte iron incorporation of stable iron isotope
Measured: study day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start25 Oct 2024
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency (Without Anemia)Studies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessica Rigutto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jessica Rigutto, Swiss Federal Institute of Technology
- Investigators
- Nicole Stoffel, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657677
- Sponsor's protocol ID
- INFER Study 1
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women.
- ClinicalTrials.gov ID
- NCT06657677
- Acronym / sponsor ID
- INFER Study 1
- Conditions
- Iron Deficiency (Without Anemia)
- Keywords
- oral iron supplementation, serum ferritin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Jessica RiguttoUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 24 Oct 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.
Serum ferritin is a key indicator of body iron stores and is widely used in monitoring iron status. However, oral iron doses can acutely elevate SF levels, potentially biasing assessments of iron stores during supplementation. This study aims to investigate the extent and duration of the acute iron-induced effect on serum ferritin, as well as its protein characteristics, following the administration of a single iron dose
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 40 mg | Experimental | Dietary Supplement: 40mg oral iron dosingsingle dose of 40 mg oral iron |
| 100 mg | Experimental | Dietary Supplement: 100mg oral iron dosingsingle dose of 100 mg oral iron |
| 180 mg | Experimental | Dietary Supplement: 180mg oral iron dosingsingle dose of 180 mg oral iron |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Low iron stores (SF levels < 30 µg/L),
- no anemia (Hb > 120 g/L)
- no inflammation (CRP < 5 mg/L)
- 18 to 45 years old.
- Body weight <70 kg
Key exclusion criteria (8 listed)
- Any chronic or acute disease
- Consumption of mineral and vitamin supplements since screening and over the study period
- Blood transfusion, blood donation or significant blood loss over the past 6 months,
- Pregnant or breastfeeding,
- Continuous/long-term use of medication during the whole studies (except for contraceptives)
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 |
|---|---|---|
| 40mg oral iron dosingParticipants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate | Dietary supplement | 40 mg |
| 100mg oral iron dosingParticipants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate | Dietary supplement | 100 mg |
| 180mg oral iron dosingParticipants will receive a single morning oral dose of iron as Fe57-labelled ferrous sulfate | Dietary supplement | 180 mg |
Primary outcome
Serum ferritin
Time frame: study day 1
Serum ferritin concentration
Serum ferritin
Time frame: study day 7
Serum ferritin concentration
27 secondary outcomes
C-reactive protein
Time frame: study day 0
Serum ferritin
Time frame: study day 0
Serum ferritin
Time frame: study day 6
Serum ferritin
Time frame: study day 14
Serum ferritin
Time frame: study day 5
Serum ferritin
Time frame: study day 4
Serum ferritin
Time frame: study day 3
Serum ferritin
Time frame: study day 2
alpha(1)-acid-glycoprotein
Time frame: study day 0
soluble transferrin receptor
Time frame: study day 0
Hemoglobin
Time frame: study day 0
Serum iron
Time frame: study day 0
Serum iron
Time frame: study day 1
Serum iron
Time frame: study day 2
Serum iron
Time frame: study day 3
Serum iron
Time frame: study day 4
Serum iron
Time frame: study day 5
Serum iron
Time frame: study day 6
Serum iron
Time frame: study day 7
Serum iron
Time frame: study day 14
Isotopic composition of Serum Ferritin
Time frame: study day 0
Isotopic composition of Serum Ferritin
Time frame: study day 2
Isotopic composition of Serum Ferritin
Time frame: study day 7
Structural characteristics of Serum Ferritin
Time frame: study day 0
Structural characteristics of Serum Ferritin
Time frame: study day 2
Structural characteristics of Serum Ferritin
Time frame: study day 7
Fractional iron absorption
Time frame: study day 14
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 27 Feb 2025.
- 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.
Nicole Stoffel, PhD principal investigator
ETH Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40mg oral iron dosing, 100mg oral iron dosing and 180mg oral iron dosing in people with Iron Deficiency (Without Anemia), run by Jessica Rigutto at 2 sites 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 6 inclusion and 8 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 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Serum ferritin (time frame: study day 1). The study lists 2 primary outcomes in all. 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 27 Feb 2025.