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

NCT ID: NCT03231865

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-27
• Study Completion Date: 2018-05-31

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.

Conditions

Iron-deficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Preoperative patients

Patients present themselves before an operation to the Anesthesiologist. They are screened for study eligibility.

Non-invasive measurement of ZincProtoporphyrin IX

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Non-invasive measurement of ZincProtoporphyrin IX

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philipp Stein

OTHER

Sponsor Role: lead

Responsible Party

Philipp Stein

Dr. med Philipp Stein

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Philipp Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Anesthesiology, University and University Hospital Zurich

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

References

Hennig G, Homann C, Teksan I, Hasbargen U, Hasmuller 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.

Reference Type: BACKGROUND

PMID: 26883939 (View on PubMed)

Other Identifiers

2017-00054

Identifier Type: -

Identifier Source: org_study_id