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临床试验/NCT06264687
NCT06264687尚未招募不适用

Serum Hepcidin Response After Intravenous Iron Therapy

Pierre-Alexandre Krayenbühl0 个研究点目标入组 10 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
主要终点
Serum Hepcidin Change

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Serum Hepcidin Change

时间窗: 1 week

The change of serum hepcidin levels over time (days 0, 2, 7) after intravenous iron administration.

次要结局

未报告次要终点

研究者

发起方
Pierre-Alexandre Krayenbühl
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pierre-Alexandre Krayenbühl

Clinical Professor

Hausarztpraxis Brauereistrasse

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Hepcidin After Intravenous Iron Treatment | 临床试验