Non-invasive Optical Detection of Iron Deficiency

Study Overview
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Brief Summary
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This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence non-invasively from the intact oral mucosa. Zinc protoporphyrin-IX is an established indicator of iron deficiency. The prototype device is used to measure the erythrocyte zinc protoporphyrin-IX/heme ratio for women after delivery, a study group chosen because of an elevated risk of iron deficiency. The results from the non-invasive measurements are compared to reference measurements of the erythrocyte zinc protoporphyrin-IX/heme ratio from residual blood samples from the same patients and to other indicators of iron status, including hemoglobin, ferritin, serum iron, transferrin, transferrin saturation and soluble transferrin receptor. Funding Source - Nestec Ltd.

Detailed Description
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This trial is a proof-of-concept study using a prototype fiber optic fluorometer to acquire autofluorescence spectra from women after delivery and determine the erythrocyte zinc protoporphyrin-IX fluorescence intensity from these spectra. The non-invasively determined fluorescence spectra are evaluated to provide a quantitative measure of the erythrocyte zinc protoporphyrin-IX/heme concentration ratio. These values are primarily compared to an erythrocyte zinc protoporphyrin-IX determined by HPLC from residual blood samples from the same subjects and secondarily to erythrocyte zinc protoporphyrin-IX/heme ratios determined using a commercial hematofluorometer (AVIV, model 206d) and other indicators of iron status, including hemoglobin, ferritin, serum iron, transferrin, transferrin saturation and soluble transferrin receptor This study could help to establish the non-invasive fluorescence measurement of zinc protoporphyrin-IX as a rapid, easy to use means for point-of-care screening for iron deficiency in resource-limited settings lacking laboratory infrastructure.

Official Title
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Non-invasive Optical Detection of Iron Deficiency - Evaluation of a Fiber Optic Tissue Fluorescence Measurement to Determine the Erythrocyte Zinc Protoporphyrin-IX/Heme Ratio

Conditions
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Anemia, Iron-Deficiency

Intervention / Treatment
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* Other: Not an interventional study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women after delivery of term infants Pregnancy and delivery without study-relevant complications Hb value pre-partum greater or equal 12 g/dL or less or equal 11 g/dL Regular blood withdrawal before and after delivery for clinical indications Informed consent to participation in the study Age 18 or older Exclusion Criteria: Patients who are not legally competent Transfusion of blood products in the course of delivery Thalassemia and sickle cell anemia Any acute or chronic infectious or inflammatory disease Insufficient amount of residual blood in the clinically indicated post partum sample

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Not an interventional study|Not an interventional study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with HPLC reference (Spearman's Rho correlation, sensitivity and specificity) | Erythrocyte zinc protoporphyrin IX in the units of μmol/mol heme, as determined from non-invasive fluorescence and remission spectroscopic measurements at the oral mucosa, compared with reference standard determinations of erythrocyte zinc protoporphyrin IX in blood samples by high performance liquid chromatography (HPLC). | 1 day after measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with estimate of body iron (sensitivity and specificity) | Erythrocyte zinc protoporphyrin IX in the units of μmol/mol heme, as determined from non-invasive fluorescence and remission spectroscopic measurements at the oral mucosa, compared with an estimate of total body iron, determined from the logarithm of the soluble transferrin receptor/ferritin ratio. | 1 day after measurement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-partum women