Non-invasive Optical Detection of Iron Deficiency in Children
Condition: Iron Deficiency; Iron-deficiency Anemia; Child
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Observational

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.
    

Detailed 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.
    

Intervention name(s): Non-invasive Iron detection device via Zinc-Protoporphyrin
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Iron detection device
Intervention MeSH terms: Iron; Protoporphyrin IX; Zinc protoporphyrin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 9 months to 5 years
      
Keywords: Iron deficiency; Child; Infancy; Preschool children; iron deficiency anemia