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临床试验/NCT03231865
NCT03231865已完成不适用

Diagnostic of Iron Deficiency by Means of Non Invasive Measurement of Zink Protoporphyrin IX

Philipp Stein1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年7月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Philipp Stein
入组人数
300
试验地点
1
主要终点
Validation of the non-invasive ZincProtoporphyrinIX measurement

研究概览

简要总结

ZnPP is being build in the case of a functional iron deficiency. Zinc instead of iron is implemented into protoporphyrin IX. This ZincProtoporphyrin (ZnPP) can be detected non invasively. Non invasive and invasive optical measurement of ZnPP will be compared. Additionally ZnPP measurements will be compared to other iron deficiency parameters for validation by the investigators.

详细描述

Zinc-protoporphyrin (ZnPP) will be measured by a fluorescence technique. Restricted wave light (407/425 nm) is used to detect ZnPP in the bloodstream non-invasively through the oral mucosa. The spectroscopic measurements are translated into a ZnPP value (mumol/mol heme).

The non-invasive measurement of ZnPP is validated and compared to optical measurement of ZnPP in whole blood and high performance liquid chromatography (HPLC) measurement of ZnPP in whole blood.

The ZnPP value is compared to other iron-deficiency parameters: Ferritin, Transferrin saturation and soluble Transferrin receptor.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients seen preoperatively in the Anesthestic clinic
  • Patients > 18 years of age
  • Understood and signed patient consent

排除标准

  • transfusion of blood products 8 weeks prior to screening
  • Pregnancy
  • Porphyria

结局指标

主要结局

Validation of the non-invasive ZincProtoporphyrinIX measurement

时间窗: Baseline

The value is compared to optical measurement of ZincProtoporphyrin in whole blood; in addition the value is compared to HPLC measurement in whole blood

次要结局

  • Comparison of the ZincProtoporyphyrinIX value to other iron-deficiency parameters(Baseline)

研究者

发起方
Philipp Stein
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Philipp Stein

Dr. med Philipp Stein

University of Zurich

研究点 (1)

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