An observational study in Iron Deficiency, Iron-deficiency Anemia and Child, sponsored by Ludwig-Maximilians - University of Munich. Completed at 2 sites in Germany. Open to participants aged 9 Months to 5 Years. Per ClinicalTrials.gov, last updated 2016-09-08.
Sponsored by Ludwig-Maximilians - University of Munich · Observational
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.
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.
782 studies on the registry are indexed under Iron Deficiencies; 114 are open to participants now.
This study's enrollment of 100 is below the median of 200 across 153 observational studies indexed under Iron Deficiencies.
Browse Iron Deficiencies studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
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Children aged 9 months to 5 years
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Exclusion Criteria:
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.
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.
Also known as: Iron detection device
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).
Time frame: 1 day after measurement
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.
Time frame: 1 day after measurement
Plan to share: Undecided — The principal investigator (PI, Prof. Dr. Dr. B. Koletzko) has access to the study data. The data may be shared with other researchers for specific research purposes if a written request with detailed description of objectives and goals, workplan and statistical analysis plan, strategy to protect data from other uses, publication strategy, and description of the research team and its qualification is provided. Based on the evaluation of proposals, the PI and study team will decided on a case by case basis which data can be provided.
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The record gives a start of Apr 2016, a primary completion of Sep 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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