Clinical trial NCT03749603: 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
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Iron Deficiency Anemia
Anemia
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-11-21
Enrollment: 1521
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Exploratory, interventional, one arm study
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Iron deficiency (ID stage I)
timeFrame: From Screening till study completion or up to 7 days, whichever comes first
measure: Prevalence of Iron deficient erythropoiesis (ID stage II)
timeFrame: From Screening till study completion or up to 7 days, whichever comes first
measure: Prevalence of iron deficiency anemia (ID stage III)
timeFrame: From Screening till study completion or up to 7 days, whichever comes first
measure: Prevalence of Anemia but no ID
timeFrame: From Screening till study completion or up to 7 days, whichever comes first
measure: Prevalence of Iron deficiency using total body iron stores (TBIS)
timeFrame: From Screening till study completion or up to 7 days, whichever comes first
measure: Prevalence of iron deficiency using the non-invasive zinc protoporphyrin (ZnPP) measurements
timeFrame: From Screening till study completion or up to 7 days, whichever comes first
Secondary outcomes:
measure: Comparison the non-invasive ZnPP with other standard blood iron status measurements
timeFrame: From Screening till study completion or up to 7 days, whichever comes first
Other outcomes:
Locations:
city: Taguig
country: Philippines
facility: Food and Nutrition Research Institute
state: Manila
Study officials:
References: