Non-invasive Optical Detection of Iron Deficiency in Children

Child Clinical Trial

— IronKids  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701309
• Other study ID #: LFL_02/2015
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: September 7, 2016
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Months to 5 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Child
• Deficiency Diseases
• Iron Deficiency
• Iron-deficiency Anemia

Intervention

Device:
• Non-invasive Iron detection device via Zinc-Protoporphyrin
In this study the feasability, sensitivity and specifity of a non-invasive detection method of zinc-protoporphyrin in children is evaluated. It´s a one-arm study, without control Group. Children are aged between 9m and 5y and have a clinical blood sampling indicated.

Locations

Country	Name	City	State
Germany	Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre	Munich	Bavaria
Germany	LMU Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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