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

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ClinicalTrials.gov Identifier: NCT03231865
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Philipp Stein, University of Zurich

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.

Condition or disease Intervention/treatment
Iron-deficiency Diagnostic Test: Non-invasive measurement of ZincProtoporphyrin IX

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 Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic of Iron Deficiency by Means of Non Invasive Measurement of Zink Protoporphyrin IX
Actual Study Start Date : July 27, 2017
Actual Primary Completion Date : February 26, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Group/Cohort Intervention/treatment
Preoperative patients
Patients present themselves before an operation to the Anesthesiologist. They are screened for study eligibility.
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




Primary Outcome Measures :
  1. Validation of the non-invasive ZincProtoporphyrinIX measurement [ Time Frame: 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 :
  1. Comparison of the ZincProtoporyphyrinIX value to other iron-deficiency parameters [ Time Frame: Baseline ]
    The value is compared to Ferritin, Transferrin saturation and soluble transferrin receptor



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients prior to a surgery, seen in the Anesthetic clinic for evaluation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231865


Locations
Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
Philipp Stein
Investigators
Principal Investigator: Philipp Stein, MD Institute of Anesthesiology, University and University Hospital Zurich

Publications:
Responsible Party: Philipp Stein, Dr. med Philipp Stein, University of Zurich
ClinicalTrials.gov Identifier: NCT03231865     History of Changes
Other Study ID Numbers: 2017-00054
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Protoporphyrin IX
Photosensitizing Agents
Dermatologic Agents