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Completed

NCT Number: NCT02310607

Non-invasive Optical Detection of Iron Deficiency

This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence non-invasively from the intact oral mucosa. Zinc protoporphyrin-IX is an established indicator of iron deficiency. The prototype device is used to measure the erythrocyte zinc protoporphyrin-IX/heme ratio for women after delivery, a study group chosen because of an elevated risk of iron deficiency. 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.

Funding Source - Nestec Ltd.

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Key information

Conditions

Anemia, Iron-Deficiency Anemia Anemia, Hypochromic Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology, Klinikum der Universitaet Muenchen, Grosshadern

Munich, D-81377, Germany

About this study

This trial is a proof-of-concept study using a prototype fiber optic fluorometer to acquire autofluorescence spectra from women after delivery 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women after delivery of term infants
  • Pregnancy and delivery without study-relevant complications
  • Hb value pre-partum greater or equal 12 g/dL or less or equal 11 g/dL
  • Regular blood withdrawal before and after delivery for clinical indications
  • Informed consent to participation in the study
  • Age 18 or older

Exclusion criteria

  • Patients who are not legally competent
  • Transfusion of blood products in the course of delivery
  • Thalassemia and sickle cell anemia
  • Any acute or chronic infectious or inflammatory disease
  • Insufficient amount of residual blood in the clinically indicated post partum sample

Treatment and study plan

Not an interventional study

Other

Not an interventional study

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

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

    Time frame: 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 an estimate of total body iron, determined from the logarithm of the soluble transferrin receptor/ferritin ratio.

Other outcomes

  1. Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with hematofluorometer (Spearman's Rho correlation, sensitivity, specificity)

    Time frame: 1 day after measurement

    Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of erythrocyte zinc protoporphyrin IX in blood samples by commercial hematofluorometer.

  2. Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with hemoglobin (sensitivity and specificity)

    Time frame: 1 day after measurement

    Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of hemoglobin in blood samples.

  3. Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with ferritin (sensitivity and specificity)

    Time frame: 1 day after measurement

    Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of ferritin in blood samples.

  4. Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with serum iron (sensitivity and specificity)

    Time frame: 1 day after measurement

    Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of serum iron in blood samples.

  5. Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with transferrin (sensitivity and specificity)

    Time frame: 1 day after measurement

    Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of transferrin in blood samples.

  6. Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with transferrin saturation (sensitivity and specificity)

    Time frame: 1 day after measurement

    Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of transferrin saturation in blood samples.

  7. Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with soluble transferrin receptor (sensitivity and specificity)

    Time frame: 1 day after measurement

    Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of soluble transferrin receptor in blood samples.

Sponsors and collaborators

Lead sponsor

Klinikum der Universitaet Muenchen, Grosshadern

Other

Registry information

Official study title

Non-invasive Optical Detection of Iron Deficiency - Evaluation of a Fiber Optic Tissue Fluorescence Measurement to Determine the Erythrocyte Zinc Protoporphyrin-IX/Heme Ratio

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 8, 2014
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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