Non-invasive Optical Detection of Iron Deficiency

Anemia, Iron-Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310607
• Other study ID #: LFL_01/2012
• Status: Completed
• Phase: N/A
• First received: December 2, 2014
• Last updated: April 7, 2015
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Klinikum der Universitaet Muenchen, Grosshadern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: The Bavarian State Ministry of the Environment and Public Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency

Intervention

Other:
• Not an interventional study
Not an interventional study

Locations

Country	Name	City	State
Germany	Department of Obstetrics and Gynecology, Klinikum der Universitaet Muenchen, Grosshadern	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen, Grosshadern

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with hematofluorometer (Spearman's Rho correlation, sensitivity, specificity)	Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of erythrocyte zinc protoporphyrin IX in blood samples by commercial hematofluorometer.	1 day after measurement	No
Other	Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with hemoglobin (sensitivity and specificity)	Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of hemoglobin in blood samples.	1 day after measurement	No
Other	Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with ferritin (sensitivity and specificity)	Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of ferritin in blood samples.	1 day after measurement	No
Other	Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with serum iron (sensitivity and specificity)	Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of serum iron in blood samples.	1 day after measurement	No
Other	Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with transferrin (sensitivity and specificity)	Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of transferrin in blood samples.	1 day after measurement	No
Other	Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with transferrin saturation (sensitivity and specificity)	Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of transferrin saturation in blood samples.	1 day after measurement	No
Other	Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with soluble transferrin receptor (sensitivity and specificity)	Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of soluble transferrin receptor in blood samples.	1 day after measurement	No
Primary	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	No
Secondary	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	No