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NCT06264687 Clinical Trial

Hepcidin After Intravenous Iron Treatment

Iron Deficiency (Without Anemia) Clinical Trial

Official title:
Serum Hepcidin Response After Intravenous Iron Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06264687
Other study ID # HepcidinIVIron
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date May 31, 2024

Study information
Verified date February 2024
Source Hausarztpraxis Brauereistrasse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to investigate the hepcidin hormone response after intravenous iron administration.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pierre-Alexandre Krayenbühl

Outcome
Type Measure Description Time frame Safety issue
Primary Serum Hepcidin Change The change of serum hepcidin levels over time (days 0, 2, 7) after intravenous iron administration. 1 week
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