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

Completed

• Conditions: Iron-deficiency
• Interventions: Diagnostic Test: Non-invasive measurement of ZincProtoporphyrin IX

• Registration Number: NCT03231865
• Lead Sponsor: Philipp Stein

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-24
• Study Start: 2017-07-27
• Study First Posted: 2017-07-27
• Primary Completion: 2018-02-26
• Study Completion: 2018-05-31
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-07
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preoperative patients	Non-invasive measurement of ZincProtoporphyrin IX	Patients present themselves before an operation to the Anesthesiologist. They are screened for study eligibility.

Primary Outcome Measures

Name	Time	Method
Validation of the non-invasive ZincProtoporphyrinIX measurement	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

Secondary Outcome Measures

Name	Time	Method
Comparison of the ZincProtoporyphyrinIX value to other iron-deficiency parameters	Baseline	The value is compared to Ferritin, Transferrin saturation and soluble transferrin receptor

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland