A Study Assessing Iron Status and Anemia in Filipino School Children From MIMAROPA Region

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study Assessing Iron Status and Anemia in Filipino School Children From MIMAROPA Region

Conditions
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Anemia, Iron-deficiency, Iron Deficiency Anemia

Intervention / Treatment
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* Device: TIBAY Meter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 6 - 11 years old Having obtained his/her informed assent. Informed consent signed by one parent or legal authorized representative if applicable. Exclusion Criteria: Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol Currently participating or having participated in another clinical trial within 4 weeks prior to trial start. Any disease of the lip and mouth that does not allow performing the lip measurement. Diagnosis of any blood disorders affecting red blood cells ( aplastic anemia, autoimmune hemolytic anemia, thalassemia) Diagnosis of any blood disorders affecting white blood cells (lymphoma, multiple myeloma, myeloplastic syndrome) Diagnosis of any blood disorders affecting platelets ( idiopathic thrombocytopenic purpura, primary thrombocythemia) Diagnosis of blood plasma ( hemophilia, von Willebrand disease) Diagnosis of acute or chronic inflammatory disease (respiratory tract, digestive tract -bowel, liver, and any kidney disease) Diagnosis of any neoplastic disease

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Exploratory, interventional, one arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIBAY meter<br>Non-invasive measurement of red blood cell Zinc Protoporphyrin (ZnPP/haem ratio-µmol/mol haem) fluorescence in the microcirculation of the lower lip. | Device: TIBAY Meter<br>* fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |