Iron Deficiency (Without Anemia)NCT06264687
Hepcidin After Intravenous Iron Treatment
An observational study of Iron Deficiency (Without Anemia), run by Pierre-Alexandre Krayenbühl.
Trial summary
The aim of this study is to investigate the hepcidin hormone response after intravenous iron administration. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Iron Deficiency (Without Anemia)
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 May 2024
- Phase
- Observational
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: iron deficient non-anemic women
Who may be able to join
- informed consent as documented by signature
- iron-deficiency (serum ferritin <30ng/ml)
- female gender
- premenopausal
- age >18 years
- body mass index (BMI) in normal range (18-25 kg/m²)
- the participant is linguistically and cognitively able to understand the study procedure
Who cannot join
- anaemia (hemoglobin <117g/l)
- allergy or contraindications for iron infusions
- anamnestic current pregnancy
- breastfeeding
- chronic inflammatory diseases (e.g. colitis)
- liver disease (alanine transaminase (ALT) >35 U/l)
- increased C-reactive protein (CRP) (>5mg/l)
- intake of dietary supplements containing iron (last 7 days)
About this study
Official title: Serum Hepcidin Response After Intravenous Iron Therapy
The aim of this study is to investigate the hepcidin hormone response after intravenous iron administration.
Read the detailed description
Intravenous iron is often administered when peroral iron is insufficient to correct iron-deficiency or not tolerated. Few studies have shown a relationship between pretherapeutic serum hepcidin levels and response to intravenous iron infusion: the lower the pre-infusion hepcidin level, the fewer red blood cell concentrates were used to correct anaemia. However, there are no studies investigating hepcidin levels after intravenous iron supplementation. Furthermore, some studies showed an increase in hepcidin 24 hours after ingesting oral iron supplements, impairing the iron uptake the next day. However, how long hepcidin is increased after intravenous iron administration is unknown. Prolonged serum hepcidin concentrations after an iron infusion would reduce intestinal iron absorption and continued, simultaneous oral iron therapy would be pointless.
This study investigates whether and how serum hepcidin concentrations change after intravenous iron therapy. Women with iron deficiency (serum ferritin below 30ng/ml) without anaemia (hemoglobin >117g/l) receive 500mg iron (Ferinject®) intravenously. Serum hepcidin levels are measured before therapy (day 0) 2 days (day 2) and 7 days (day 7) after infusion.
- Conditions
- Iron Deficiency (Without Anemia)
- Medical subject headings
- Iron Deficiencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Hepcidin Change
The change of serum hepcidin levels over time (days 0, 2, 7) after intravenous iron administration.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre-Alexandre Krayenbühl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pierre-Alexandre Krayenbühl, Hausarztpraxis Brauereistrasse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264687
- Sponsor's protocol ID
- HepcidinIVIron
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Hepcidin Response After Intravenous Iron Therapy
- ClinicalTrials.gov ID
- NCT06264687
- Acronym / sponsor ID
- HepcidinIVIron
- Conditions
- Iron Deficiency (Without Anemia)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pierre-Alexandre KrayenbühlUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 20 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 aim of this study is to investigate the hepcidin hormone response after intravenous iron administration.
Detailed description
Intravenous iron is often administered when peroral iron is insufficient to correct iron-deficiency or not tolerated. Few studies have shown a relationship between pretherapeutic serum hepcidin levels and response to intravenous iron infusion: the lower the pre-infusion hepcidin level, the fewer red blood cell concentrates were used to correct anaemia. However, there are no studies investigating hepcidin levels after intravenous iron supplementation. Furthermore, some studies showed an increase in hepcidin 24 hours after ingesting oral iron supplements, impairing the iron uptake the next day. However, how long hepcidin is increased after intravenous iron administration is unknown. Prolonged serum hepcidin concentrations after an iron infusion would reduce intestinal iron absorption and continued, simultaneous oral iron therapy would be pointless.
This study investigates whether and how serum hepcidin concentrations change after intravenous iron therapy. Women with iron deficiency (serum ferritin below 30ng/ml) without anaemia (hemoglobin >117g/l) receive 500mg iron (Ferinject®) intravenously. Serum hepcidin levels are measured before therapy (day 0) 2 days (day 2) and 7 days (day 7) after infusion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- iron deficient non-anemic women
Key inclusion criteria (7 listed)
- informed consent as documented by signature
- iron-deficiency (serum ferritin <30ng/ml)
- female gender
- premenopausal
- age >18 years
Key exclusion criteria (8 listed)
- anaemia (hemoglobin <117g/l)
- allergy or contraindications for iron infusions
- anamnestic current pregnancy
- breastfeeding
- chronic inflammatory diseases (e.g. colitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Hepcidin Change
Time frame: 1 week
The change of serum hepcidin levels over time (days 0, 2, 7) after intravenous iron administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency (Without Anemia), run by Pierre-Alexandre Krayenbühl.
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 7 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 Hepcidin Change (time frame: 1 week). 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 20 Feb 2024.