跳至主要内容
临床试验/NCT02701309
NCT02701309已完成不适用

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

Ludwig-Maximilians - University of Munich2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with HPLC reference (Spearman's Rho correlation, sensitivity and specificity)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
9 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with HPLC reference (Spearman's Rho correlation, sensitivity and specificity)

时间窗: 1 day after measurement

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).

次要结局

  • Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with estimate of body iron (sensitivity and specificity)(1 day after measurement)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Koletzko - Office

Prof. Dr.

Ludwig-Maximilians - University of Munich

研究点 (2)

Loading locations...

相似试验

Non-invasive Optical Detection of Iron Deficiency in... | 临床试验