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Non-invasive Optical Detection of Iron Deficiency

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ClinicalTrials.gov Identifier: NCT02310607
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Uwe Hasbargen, Klinikum der Universitaet Muenchen, Grosshadern

Brief Summary:

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.


Condition or disease Intervention/treatment
Anemia, Iron-Deficiency Other: Not an interventional study

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 96 participants
Time Perspective: Prospective
Official 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
Study Start Date : June 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron


Intervention Details:
  • Other: Not an interventional study
    Not an interventional study


Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women post-partum
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310607


Locations
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Germany
Department of Obstetrics and Gynecology, Klinikum der Universitaet Muenchen, Grosshadern
Munich, Germany, D-81377
Sponsors and Collaborators
Klinikum der Universitaet Muenchen, Grosshadern
Investigators
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Principal Investigator: Uwe Hasbargen, PD Dr. med. Klinikum der Universitaet Muenchen
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Responsible Party: Dr. Uwe Hasbargen, PD Dr. med., Klinikum der Universitaet Muenchen, Grosshadern
ClinicalTrials.gov Identifier: NCT02310607    
Other Study ID Numbers: LFL_01/2012
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
Keywords provided by Dr. Uwe Hasbargen, Klinikum der Universitaet Muenchen, Grosshadern:
Post-partum women
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases