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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1521 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2019-05-20

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.

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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.

Conditions

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Iron-deficiency Iron Deficiency Anemia Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Exploratory, interventional, one arm study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

no masking required. assessments are both done on same subjects.

Study Groups

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TIBAY meter

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

Group Type EXPERIMENTAL

TIBAY Meter

Intervention Type DEVICE

fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.

Interventions

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TIBAY Meter

fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes