Hepcidin After Intravenous Iron Treatment

Serum Hepcidin Response After Intravenous Iron Therapy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Iron Deficiency (Without Anemia)

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 Type: Observational
• Enrollment (Estimated): 10

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

iron deficient non-anemic women

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pierre-Alexandre Krayenbühl

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Deficiencies
• Other Study ID Numbers: HepcidinIVIron

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No