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

March 22, 2023 updated by: Société des Produits Nestlé (SPN)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1521

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • Manila
      • Taguig, Manila, Philippines
        • Food and Nutrition Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: TIBAY Meter
fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Iron deficiency (ID stage I)
Time Frame: 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
From Screening till study completion or up to 7 days, whichever comes first
Prevalence of Iron deficient erythropoiesis (ID stage II)
Time Frame: 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
From Screening till study completion or up to 7 days, whichever comes first
Prevalence of iron deficiency anemia (ID stage III)
Time Frame: 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
From Screening till study completion or up to 7 days, whichever comes first
Prevalence of Anemia but no ID
Time Frame: 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
From Screening till study completion or up to 7 days, whichever comes first
Prevalence of Iron deficiency using total body iron stores (TBIS)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
From Screening till study completion or up to 7 days, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2019

Primary Completion (Actual)

May 20, 2019

Study Completion (Actual)

May 20, 2019

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

November 19, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18.10.DAI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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