Non-invasive Optical Detection of Iron Deficiency in Children (IronKids)

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Iron Deficiency; Child; Iron-deficiency Anemia

Treatments: Device: Non-invasive Iron detection device via Zinc-Protoporphyrin

Study type: Observational

Funder types: Other

Identifiers

NCT02701309

LFL_02/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 9 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Non-invasive Iron detection

Description:

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.

Treatment:

Device: Non-invasive Iron detection device via Zinc-Protoporphyrin