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The purpose of this study is to assess the iron status and to confirm the usability of the non-invasive ZnPP measurement for screening the different stages of iron deficiency defined by standard measurements from blood.
Brief description: The purpose of this study is to assess the iron status and to confirm the usability of the non-invasive ZnPP measurement for screening the different stages of iron deficiency defined by standard measurements from blood.
Detailed Description:
The primary objective of this study is to assess the iron status and the prevalence of the different stages of iron deficiency measured and defined by the standard blood iron measurements and by the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip.
The secondary objective is to compare and to assess the usability of the non-invasive ZnPP measurement versus other standard iron status measurements from blood in distinguishing the different stages of iron deficiency.
Subjects will be enrolled into the study after signing an assent form in addition to having parental informed consent signed. Total study duration is 1 day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIBAY meter | Experimental | Non-invasive measurement of red blood cell Zinc Protoporphyrin (ZnPP/haem ratio-µmol/mol haem) fluorescence in the microcirculation of the lower lip. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIBAY Meter | Device | fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Iron deficiency (ID stage I) | Iron status / prevalence of different stages of iron deficiency (ID) measured and defined by the standard blood iron measurements and the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip | From Screening till study completion or up to 7 days, whichever comes first |
| Prevalence of Iron deficient erythropoiesis (ID stage II) | Iron status / prevalence of different stages of iron deficiency (ID) measured and defined by the standard blood iron measurements and the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip | From Screening till study completion or up to 7 days, whichever comes first |
| Prevalence of iron deficiency anemia (ID stage III) | Iron status / prevalence of different stages of iron deficiency (ID) measured and defined by the standard blood iron measurements and the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip | From Screening till study completion or up to 7 days, whichever comes first |
| Prevalence of Anemia but no ID | Iron status / prevalence of different stages of iron deficiency (ID) measured and defined by the standard blood iron measurements and the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip | From Screening till study completion or up to 7 days, whichever comes first |
| Prevalence of Iron deficiency using total body iron stores (TBIS) | Iron status / prevalence of different stages of iron deficiency (ID) measured and defined by the standard blood iron measurements and the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison the non-invasive ZnPP with other standard blood iron status measurements | Comparison the non-invasive ZnPP with other standard blood iron status measurements for (ferritin, soluble transferrin receptor, hemoglobin) By comparing accuracy/ sensitivity/ specificity/ positive predictive value/negative predictive value/ ROC curve | From Screening till study completion or up to 7 days, whichever comes first |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Food and Nutrition Research Institute | City of Taguig | Manila | Philippines |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
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Exploratory, interventional, one arm study
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no masking required. assessments are both done on same subjects.
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| From Screening till study completion or up to 7 days, whichever comes first |
| Prevalence of iron deficiency using the non-invasive zinc protoporphyrin (ZnPP) measurements | Iron status / prevalence of different stages of iron deficiency (ID) measured and defined by the standard blood iron measurements and the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip | From Screening till study completion or up to 7 days, whichever comes first |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |