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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749603
• Other study ID #: 18.10.DAI
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: May 20, 2019

Study information

• Verified date: March 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1521
• Est. completion date: May 20, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Iron-deficiency

Intervention

Device:
• TIBAY Meter
fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.

Locations

Country	Name	City	State
Philippines	Food and Nutrition Research Institute	Taguig	Manila

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From Screening till study completion or up to 7 days, whichever comes first
Primary	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	From Screening till study completion or up to 7 days, whichever comes first
Primary	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	From Screening till study completion or up to 7 days, whichever comes first
Primary	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	From Screening till study completion or up to 7 days, whichever comes first
Primary	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	From Screening till study completion or up to 7 days, whichever comes first
Primary	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	From Screening till study completion or up to 7 days, whichever comes first
Secondary	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	From Screening till study completion or up to 7 days, whichever comes first