Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not an interventional study | Other | Not an interventional study |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 day after measurement |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with hematofluorometer (Spearman's Rho correlation, sensitivity, specificity) | Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of erythrocyte zinc protoporphyrin IX in blood samples by commercial hematofluorometer. | 1 day after measurement |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Women post-partum
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Uwe Hasbargen, PD Dr. med. | LMU Klinikum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Klinikum der Universitaet Muenchen, Grosshadern | Munich | D-81377 | Germany |
Not provided
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 day after measurement |
| Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with hemoglobin (sensitivity and specificity) | Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of hemoglobin in blood samples. | 1 day after measurement |
| Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with ferritin (sensitivity and specificity) | Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of ferritin in blood samples. | 1 day after measurement |
| Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with serum iron (sensitivity and specificity) | Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of serum iron in blood samples. | 1 day after measurement |
| Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with transferrin (sensitivity and specificity) | Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of transferrin in blood samples. | 1 day after measurement |
| Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with transferrin saturation (sensitivity and specificity) | Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of transferrin saturation in blood samples. | 1 day after measurement |
| Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with soluble transferrin receptor (sensitivity and specificity) | Comparison of non-invasive optical measurements of erythrocyte zinc protoporphyrin IX with determinations of soluble transferrin receptor in blood samples. | 1 day after measurement |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |