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

June 7, 2018 updated by: Philipp Stein
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients prior to a surgery, seen in the Anesthetic clinic for evaluation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipp Stein

Investigators

  • Principal Investigator: Philipp Stein, MD, Institute of Anesthesiology, University and University Hospital Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2017

Primary Completion (Actual)

February 26, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 8, 2018

Last Update Submitted That Met QC Criteria

June 7, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-00054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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