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Completed

NCT Number: NCT03231865

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

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.

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive measurement of ZincProtoporphyrin IX

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Philipp Stein

Other

Registry information

Acronym: ZnPP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 27, 2017
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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