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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03231865
Acronym
ZnPP
Enrollment
300
Registered
2017-07-27
Start date
2017-07-27
Completion date
2018-05-31
Last updated
2018-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron-deficiency

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.

Interventions

DIAGNOSTIC_TESTNon-invasive measurement of ZincProtoporphyrin IX

Within 30 seconds, a measurement is performed on the lip of a patient to determine a ZincProtoporphyrin value

Sponsors

Philipp Stein
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Validation of the non-invasive ZincProtoporphyrinIX measurementBaselineThe value is compared to optical measurement of ZincProtoporphyrin in whole blood; in addition the value is compared to HPLC measurement in whole blood

Secondary

MeasureTime frameDescription
Comparison of the ZincProtoporyphyrinIX value to other iron-deficiency parametersBaselineThe value is compared to Ferritin, Transferrin saturation and soluble transferrin receptor

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026