Anemia, Iron-deficiency, Iron Deficiency Anemia
Conditions
Brief summary
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
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.
Interventions
DEVICETIBAY Meter
fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
no masking required. assessments are both done on same subjects.
Intervention model description
Exploratory, interventional, one arm study
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 6 - 11 years old 2. Having obtained his/her informed assent. 3. Informed consent signed by one parent or legal authorized representative if applicable.
Exclusion criteria
1. 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 2. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start. 3. Any disease of the lip and mouth that does not allow performing the lip measurement. 4. Diagnosis of any blood disorders affecting red blood cells ( aplastic anemia, autoimmune hemolytic anemia, thalassemia) 5. Diagnosis of any blood disorders affecting white blood cells (lymphoma, multiple myeloma, myeloplastic syndrome) 6. Diagnosis of any blood disorders affecting platelets ( idiopathic thrombocytopenic purpura, primary thrombocythemia) 7. Diagnosis of blood plasma ( hemophilia, von Willebrand disease) 8. Diagnosis of acute or chronic inflammatory disease (respiratory tract, digestive tract -bowel, liver, and any kidney disease) 9. Diagnosis of any neoplastic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of iron deficiency anemia (ID stage III) | From Screening till study completion or up to 7 days, whichever comes first | 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 |
| Prevalence of Iron deficient erythropoiesis (ID stage II) | From Screening till study completion or up to 7 days, whichever comes first | 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 |
| Prevalence of Iron deficiency (ID stage I) | From Screening till study completion or up to 7 days, whichever comes first | 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 |
| Prevalence of iron deficiency using the non-invasive zinc protoporphyrin (ZnPP) measurements | From Screening till study completion or up to 7 days, whichever comes first | 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 |
| Prevalence of Anemia but no ID | From Screening till study completion or up to 7 days, whichever comes first | 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 |
| Prevalence of Iron deficiency using total body iron stores (TBIS) | From Screening till study completion or up to 7 days, whichever comes first | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison the non-invasive ZnPP with other standard blood iron status measurements | From Screening till study completion or up to 7 days, whichever comes first | 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 |
Countries
Philippines
Outcome results
None listed