Hepcidin After Intravenous Iron Treatment

NCT ID: NCT06264687

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-05-31

Brief Summary

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.

Conditions

Iron Deficiency (Without Anemia)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pierre-Alexandre Krayenbühl

OTHER

Sponsor Role: lead

Responsible Party

Pierre-Alexandre Krayenbühl

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

HepcidinIVIron

Identifier Type: -

Identifier Source: org_study_id