Non-invasive Optical Detection of Iron Deficiency in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-09-30

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 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.

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Detailed Description

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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.

Conditions

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Iron Deficiency Iron-deficiency Anemia Child

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-invasive Iron detection

Children between 9months and 5years will be recruited for a non-invasive iron measurement on the lower lip. This study is focusing on the feasability of a non-invasive detection method. There is no intervention planed. The device is tested once for 3-5 Minutes.

Non-invasive Iron detection device via Zinc-Protoporphyrin

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Iron detection device

Eligibility Criteria

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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

Minimum Eligible Age

9 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No