Iron Deficiency (Without Anemia)NCT04735848
Plasma Hepcidin Response to Differently Dosed Iron Supplements
A study testing Iron-supplement application in people with Iron Deficiency (Without Anemia), run by Pierre-Alexandre Krayenbuehl at 1 site in Switzerland.
Trial summary
The study participants will take 3 different doses of iron supplements at 8 am, on 3 different days. By taking blood samples in the morning and afternoon, the investigators will determine the effects of the iron supplements on plasma hepcidin and compare them to baseline plasma hepcidin values. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency (Without Anemia)
- What is being tested?
- Iron-supplement application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2021to 31 Aug 2021
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature
- Female gender
- Premenopausal
- Age > 18 years
- Regular menstrual cycle
- BMI in normal range (18-25kg/m2)
Show all 9Show fewer
- Serum-ferritin ≤30ng/ml
- No anemia
- No intake of dietary supplements
Who cannot join
- Intake of dietary supplements
- Pregnancy
- Hypermenorrhea (> 80ml blood loss, or more than 5 unties/tampons per day)
- Anemia
- Serum-ferritin >30ng/ml
- BMI <18 kg/m2 or >25 kg/m2
- Chronic inflammatory disease
- Hypersensitivity to iron supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center Clinical Trial to Evaluate the Effect of Different Amounts of Iron Supplements on the Plasma Hepcidin Level in Non-anemic Iron-deficient Females
The study participants will take 3 different doses of iron supplements at 8 am, on 3 different days. By taking blood samples in the morning and afternoon, the investigators will determine the effects of the iron supplements on plasma hepcidin and compare them to baseline plasma hepcidin values.
Read the detailed description
15 healthy young women with non-anemic iron deficiency will participate in the study. On 4 different days the investigators will take two blood samples (one in the morning at 8 am, before the iron intake and one in the afternoon at 4 pm) to determine the plasma hepcidin level. The intake of the iron supplements will be at least 48 hours apart from each other, to exclude any impacts of the previous iron intake to the next measurement.
The participants will take the iron supplement supervised at 8 am after overnight fasting.
All blood samples will be performed for analysis of CRP and hepcidin. The investigators will measure the CRP in the blood sample to exclude any impacts of inflammation to the hepcidin measurement and use a CRP ≤5mg/l as a cut-off. If the CRP is higher than 5mg/l the investigators will exclude the measurement from our analyses and repeat the measurement at another day.
The first two blood samples will be taken at 8 am and at 4 pm on the same day and after overnight fasting to find the baseline hepcidin, the other blood samples will be taken at 8 am before the iron intake and at 4 pm also on the same day and also after overnight fasting.
- Conditions
- Iron Deficiency (Without Anemia)
- Being tested
- Iron-supplement application
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron-supplement applicationDietary supplement
The participants will take the corresponding amount of iron-supplement supervised at 8am.
| Study group | Role | What they receive |
|---|---|---|
| 6mg iron-supplement | Experimental | All participants will be in this arm. Everyone will take all three different doses of iron-supplement (6mg; 30mg;60mg). Receives: Dietary Supplement: Iron-supplement application |
| 30mg iron-supplement | Experimental | All participants will be in this arm. Everyone will take all three different doses of iron-supplement (6mg; 30mg;60mg). Receives: Dietary Supplement: Iron-supplement application |
| 60mg iron-supplement | Experimental | All participants will be in this arm. Everyone will take all three different doses of iron-supplement (6mg; 30mg;60mg). Receives: Dietary Supplement: Iron-supplement application |
| Baseline | No intervention | Baseline measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma hepcidin change
The investigators will measure the plasma hepcidin level of the patients in the morning at 8am, (right before the intake of the iron-supplement) as well as in the afternoon at 4pm. The investigators will also measure the plasma hepcidin level on a baseline day (at the same times), when the patients don't take any iron supplement. By these measurements the investigators will report the change in the plasma hepcidin level after the intake of an iron-supplement.
Measured: The hepcidin measurement of all samples will be done after the last blood sample of the last participant is taken. Which is planed to be done up to 6 month from the first baseline visit.
Secondary outcomes (1)
Dose-response relationship between iron and hepcidin
In addition, the investigators will estimate a linear relationship (slope) between the iron dose and the plasma hepcidin level, using dose as a continuous explanatory factor in the model. The investigators will report a dose dependent assessment of the plasma hepcidin level.
Measured: The hepcidin measurement of all samples will be done after the last blood sample of the last participant is taken. Which is planed to be done up to 6 month from the first baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Jun 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The participants will take all three different doses of iron and will serve as there own control
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre-Alexandre Krayenbuehl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pierre-Alexandre Krayenbuehl, University of Zurich
- Investigators
- Pierre-Alexandre Krayenbühl, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735848
- Sponsor's protocol ID
- Plasma hepcidin response
- Status last verified
- Oct 2021
- First submitted
- 19 Jan 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karczewski M, Simic S, Saleh L, Nowak A, Schubert MG, Moretti D, Swinkels DW, Beuschlein F, Suter PM, Krayenbuehl PA. The magnitude of the plasma hepcidin response to oral iron supplements depends on the iron dosage. Swiss Med Wkly. 2024 Feb 19;154:3635. doi: 10.57187/s.3635.
PubMed 38579297
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Clinical Trial to Evaluate the Effect of Different Amounts of Iron Supplements on the Plasma Hepcidin Level in Non-anemic Iron-deficient Females
- ClinicalTrials.gov ID
- NCT04735848
- Acronym / sponsor ID
- Plasma hepcidin response
- Conditions
- Iron Deficiency (Without Anemia)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pierre-Alexandre KrayenbuehlUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 3 Feb 2021 (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 study participants will take 3 different doses of iron supplements at 8 am, on 3 different days. By taking blood samples in the morning and afternoon, the investigators will determine the effects of the iron supplements on plasma hepcidin and compare them to baseline plasma hepcidin values.
Detailed description
15 healthy young women with non-anemic iron deficiency will participate in the study. On 4 different days the investigators will take two blood samples (one in the morning at 8 am, before the iron intake and one in the afternoon at 4 pm) to determine the plasma hepcidin level. The intake of the iron supplements will be at least 48 hours apart from each other, to exclude any impacts of the previous iron intake to the next measurement.
The participants will take the iron supplement supervised at 8 am after overnight fasting.
All blood samples will be performed for analysis of CRP and hepcidin. The investigators will measure the CRP in the blood sample to exclude any impacts of inflammation to the hepcidin measurement and use a CRP ≤5mg/l as a cut-off. If the CRP is higher than 5mg/l the investigators will exclude the measurement from our analyses and repeat the measurement at another day.
The first two blood samples will be taken at 8 am and at 4 pm on the same day and after overnight fasting to find the baseline hepcidin, the other blood samples will be taken at 8 am before the iron intake and at 4 pm also on the same day and also after overnight fasting.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The participants will take all three different doses of iron and will serve as there own control
| Arm | Type | Receives |
|---|---|---|
| 6mg iron-supplement | Experimental | Dietary Supplement: Iron-supplement applicationAll participants will be in this arm. Everyone will take all three different doses of iron-supplement (6mg; 30mg;60mg). |
| 30mg iron-supplement | Experimental | Dietary Supplement: Iron-supplement applicationAll participants will be in this arm. Everyone will take all three different doses of iron-supplement (6mg; 30mg;60mg). |
| 60mg iron-supplement | Experimental | Dietary Supplement: Iron-supplement applicationAll participants will be in this arm. Everyone will take all three different doses of iron-supplement (6mg; 30mg;60mg). |
| Baseline | No intervention | –Baseline measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed Consent as documented by signature
- Female gender
- Premenopausal
- Age > 18 years
- Regular menstrual cycle
Key exclusion criteria (8 listed)
- Intake of dietary supplements
- Pregnancy
- Hypermenorrhea (> 80ml blood loss, or more than 5 unties/tampons per day)
- Anemia
- Serum-ferritin >30ng/ml
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 |
|---|---|---|
| Iron-supplement applicationThe participants will take the corresponding amount of iron-supplement supervised at 8am. | Dietary supplement | 30mg iron-supplement, 60mg iron-supplement, 6mg iron-supplement |
Primary outcome
Plasma hepcidin change
Time frame: The hepcidin measurement of all samples will be done after the last blood sample of the last participant is taken. Which is planed to be done up to 6 month from the first baseline visit.
The investigators will measure the plasma hepcidin level of the patients in the morning at 8am, (right before the intake of the iron-supplement) as well as in the afternoon at 4pm. The investigators will also measure the plasma hepcidin level on a baseline day (at the same times), when the patients don't take any iron supplement. By these measurements the investigators will report the change in the plasma hepcidin level after the intake of an iron-supplement.
1 secondary outcome
Dose-response relationship between iron and hepcidin
Time frame: The hepcidin measurement of all samples will be done after the last blood sample of the last participant is taken. Which is planed to be done up to 6 month from the first baseline visit.
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 8 Oct 2021.
- Derived from this study: PubMed 38579297Karczewski M, Simic S, Saleh L, Nowak A, Schubert MG, Moretti D, Swinkels DW, Beuschlein F, Suter PM, Krayenbuehl PA. The magnitude of the plasma hepcidin response to oral iron supplements depends on the iron dosage. Swiss Med Wkly. 2024 Feb 19;154:3635. doi: 10.57187/s.3635.
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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.
Pierre-Alexandre Krayenbühl principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron-supplement application in people with Iron Deficiency (Without Anemia), run by Pierre-Alexandre Krayenbuehl 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 9 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 8 Oct 2021. 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.
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?
Plasma hepcidin change (time frame: The hepcidin measurement of all samples will be done after the last blood sample of the last participant is taken. Which is planed to be done up to 6 month from the first baseline visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735848, which also lists 1 linked publication.
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 8 Oct 2021.