Clinical trial NCT02310607: Non-invasive Optical Detection of Iron Deficiency
Official title: Non-invasive Optical Detection of Iron Deficiency - Evaluation of a Fiber Optic Tissue Fluorescence Measurement to Determine the Erythrocyte Zinc Protoporphyrin-IX/Heme Ratio
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Iron-Deficiency
Keywords: Post-partum women
Lead sponsor: Klinikum der Universitaet Muenchen, Grosshadern
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women post-partum

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with HPLC reference (Spearman's Rho correlation, sensitivity and specificity)
timeFrame: 1 day after measurement
Secondary outcomes:
measure: Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with estimate of body iron (sensitivity and specificity)
timeFrame: 1 day after measurement
Other outcomes:
measure: Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with hematofluorometer (Spearman's Rho correlation, sensitivity, specificity)
timeFrame: 1 day after measurement
measure: Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with hemoglobin (sensitivity and specificity)
timeFrame: 1 day after measurement
measure: Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with ferritin (sensitivity and specificity)
timeFrame: 1 day after measurement
measure: Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with serum iron (sensitivity and specificity)
timeFrame: 1 day after measurement
measure: Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with transferrin (sensitivity and specificity)
timeFrame: 1 day after measurement
measure: Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with transferrin saturation (sensitivity and specificity)
timeFrame: 1 day after measurement
measure: Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with soluble transferrin receptor (sensitivity and specificity)
timeFrame: 1 day after measurement
Locations:
city: Munich
country: Germany
facility: Department of Obstetrics and Gynecology, Klinikum der Universitaet Muenchen, Grosshadern
Study officials:
affiliation: LMU Klinikum
name: Uwe Hasbargen, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: