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

Primary Purpose

Iron-deficiency, Iron Deficiency Anemia, Anemia

Status
Completed
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
TIBAY Meter
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Iron-deficiency

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts 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

Sites / Locations

  • Food and Nutrition Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TIBAY meter

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
October 4, 2018
Last Updated
March 22, 2023
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT03749603
Brief Title
A Study Assessing Iron Status and Anemia in Filipino School Children From MIMAROPA Region
Official Title
A Study Assessing Iron Status and Anemia in Filipino School Children From MIMAROPA Region
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
May 20, 2019 (Actual)
Study Completion Date
May 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency, Iron Deficiency Anemia, Anemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Exploratory, interventional, one arm study
Masking
None (Open Label)
Masking Description
no masking required. assessments are both done on same subjects.
Allocation
N/A
Enrollment
1521 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIBAY meter
Arm Type
Experimental
Arm Description
Non-invasive measurement of red blood cell Zinc Protoporphyrin (ZnPP/haem ratio-µmol/mol haem) fluorescence in the microcirculation of the lower lip.
Intervention Type
Device
Intervention Name(s)
TIBAY Meter
Intervention Description
fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.
Primary Outcome Measure Information:
Title
Prevalence of Iron deficiency (ID stage I)
Description
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
Time Frame
From Screening till study completion or up to 7 days, whichever comes first
Title
Prevalence of Iron deficient erythropoiesis (ID stage II)
Description
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
Time Frame
From Screening till study completion or up to 7 days, whichever comes first
Title
Prevalence of iron deficiency anemia (ID stage III)
Description
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
Time Frame
From Screening till study completion or up to 7 days, whichever comes first
Title
Prevalence of Anemia but no ID
Description
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
Time Frame
From Screening till study completion or up to 7 days, whichever comes first
Title
Prevalence of Iron deficiency using total body iron stores (TBIS)
Description
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
Time Frame
From Screening till study completion or up to 7 days, whichever comes first
Title
Prevalence of iron deficiency using the non-invasive zinc protoporphyrin (ZnPP) measurements
Description
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
Time Frame
From Screening till study completion or up to 7 days, whichever comes first
Secondary Outcome Measure Information:
Title
Comparison the non-invasive ZnPP with other standard blood iron status measurements
Description
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
Time Frame
From Screening till study completion or up to 7 days, whichever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Food and Nutrition Research Institute
City
Taguig
State/Province
Manila
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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