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

Nestlé

Status: Completed

Conditions: Anemia; Iron Deficiency Anemia; Iron-deficiency

Treatments: Device: TIBAY Meter

Study type: Interventional

Funder types: Industry

Identifiers

NCT03749603

18.10.DAI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,521 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,521 participants in 1 patient group

TIBAY meter

Experimental group

Description:

Non-invasive measurement of red blood cell Zinc Protoporphyrin (ZnPP/haem ratio-µmol/mol haem) fluorescence in the microcirculation of the lower lip.

Treatment:

Device: TIBAY Meter