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

Iron-deficiency Clinical Trial

— ZnPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231865
• Other study ID #: 2017-00054
• Status: Completed
• Start date: July 27, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: June 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 31, 2018
• Est. primary completion date: February 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

Diagnostic Test:
• Non-invasive measurement of ZincProtoporphyrin IX
Within 30 seconds, a measurement is performed on the lip of a patient to determine a ZincProtoporphyrin value

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Philipp Stein

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Hennig G, Homann C, Teksan I, Hasbargen U, Hasmüller S, Holdt LM, Khaled N, Sroka R, Stauch T, Stepp H, Vogeser M, Brittenham GM. Non-invasive detection of iron deficiency by fluorescence measurement of erythrocyte zinc protoporphyrin in the lip. Nat Commun. 2016 Feb 17;7:10776. doi: 10.1038/ncomms10776. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of the non-invasive ZincProtoporphyrinIX measurement	The value is compared to optical measurement of ZincProtoporphyrin in whole blood; in addition the value is compared to HPLC measurement in whole blood	Baseline
Secondary	Comparison of the ZincProtoporyphyrinIX value to other iron-deficiency parameters	The value is compared to Ferritin, Transferrin saturation and soluble transferrin receptor	Baseline