Clinical trial NCT02701309: Non-invasive Optical Detection of Iron Deficiency in Children
Official title: Non-invasive Optical Detection of Iron Deficiency in Children- Evaluation of a Fiber Optic Tissue Fluorescence Measurement to Determine the Erythrocyte Zinc Protoporphyrin-IX/Heme Ratio
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency
Iron-deficiency Anemia
Child
Keywords: Iron deficiency
Child
Infancy
Preschool children
iron deficiency anemia
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 9
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 9 months to 5 years

Brief summary: This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence non-invasively from the intact oral mucosa in children. The prototype device has shown high sensitivity and specificity in women after delivery for iron deficiency. Children are at increased risk for iron deficiency and prevention methods are not established jet. Zinc protoporphyrin-IX is an early indicator of iron deficiency and may be more sensitive than other established parameters. The prototype device is used to measure the erythrocyte zinc protoporphyrin-IX/heme ratio in children aged 9 months to 5 years. Children in this age are at increased risk for iron deficiency as they are growing rapidly and iron deficiency in this age may affect the neurodevelopment and immune system adversely. It is proposed that these effects cannot be rectified by iron supplementation in later years. 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.

Detailed description: This trial is a proof-of-concept study using a prototype fiber optic fluorometer to acquire autofluorescence spectra in children aged 9 months to 5 years 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:

* Children aged 9 months to 5 years
* Planed blood sampling, independently from this study
* Informed written consent to participation´s guardian in the study

Exclusion Criteria:

* the ability of the guardian is not given to approve the consent
* transfusion of blood products before entering the study
* blood sampling is not planed for clinical investigations

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:
Locations:
city: Munich
country: Germany
facility: Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre
state: Bavaria
city: Munich
country: Germany
facility: LMU Munich
state: Bavaria
Study officials:
affiliation: LMU Munich, Germany
name: Berthold Koletzko, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: