<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03749603</url>
  </required_header>
  <id_info>
    <org_study_id>18.10.DAI</org_study_id>
    <nct_id>NCT03749603</nct_id>
  </id_info>
  <brief_title>A Study Assessing Iron Status and Anemia in Filipino School Children From MIMAROPA Region</brief_title>
  <official_title>A Study Assessing Iron Status and Anemia in Filipino School Children From MIMAROPA Region</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the iron status and to confirm the usability of the&#xD;
      non-invasive ZnPP measurement for screening the different stages of iron deficiency defined&#xD;
      by standard measurements from blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Brief description: The purpose of this study is to assess the iron status and to confirm the&#xD;
      usability of the non-invasive ZnPP measurement for screening the different stages of iron&#xD;
      deficiency defined by standard measurements from blood.&#xD;
&#xD;
      Detailed Description:&#xD;
&#xD;
      The primary objective of this study is to assess the iron status and the prevalence of the&#xD;
      different stages of iron deficiency measured and defined by the standard blood iron&#xD;
      measurements and by the non-invasive measurement of red blood cell Zinc Protoporphyrin&#xD;
      fluorescence in the microcirculation of the lower lip.&#xD;
&#xD;
      The secondary objective is to compare and to assess the usability of the non-invasive ZnPP&#xD;
      measurement versus other standard iron status measurements from blood in distinguishing the&#xD;
      different stages of iron deficiency.&#xD;
&#xD;
      Subjects will be enrolled into the study after signing an assent form in addition to having&#xD;
      parental informed consent signed. Total study duration is 1 day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">May 20, 2019</completion_date>
  <primary_completion_date type="Actual">May 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Exploratory, interventional, one arm study</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>no masking required. assessments are both done on same subjects.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of Iron deficiency (ID stage I)</measure>
    <time_frame>From Screening till study completion or up to 7 days, whichever comes first</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of Iron deficient erythropoiesis (ID stage II)</measure>
    <time_frame>From Screening till study completion or up to 7 days, whichever comes first</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of iron deficiency anemia (ID stage III)</measure>
    <time_frame>From Screening till study completion or up to 7 days, whichever comes first</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of Anemia but no ID</measure>
    <time_frame>From Screening till study completion or up to 7 days, whichever comes first</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of Iron deficiency using total body iron stores (TBIS)</measure>
    <time_frame>From Screening till study completion or up to 7 days, whichever comes first</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of iron deficiency using the non-invasive zinc protoporphyrin (ZnPP) measurements</measure>
    <time_frame>From Screening till study completion or up to 7 days, whichever comes first</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison the non-invasive ZnPP with other standard blood iron status measurements</measure>
    <time_frame>From Screening till study completion or up to 7 days, whichever comes first</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1521</enrollment>
  <condition>Iron-deficiency</condition>
  <condition>Iron Deficiency Anemia</condition>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>TIBAY meter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-invasive measurement of red blood cell Zinc Protoporphyrin (ZnPP/haem ratio-µmol/mol haem) fluorescence in the microcirculation of the lower lip.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TIBAY Meter</intervention_name>
    <description>fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.</description>
    <arm_group_label>TIBAY meter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 6 - 11 years old&#xD;
&#xD;
          2. Having obtained his/her informed assent.&#xD;
&#xD;
          3. Informed consent signed by one parent or legal authorized representative if&#xD;
             applicable.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects or subjects' parent(s) or legal representative who are not willing and not&#xD;
             able to comply with scheduled visits and the requirements of the study protocol&#xD;
&#xD;
          2. Currently participating or having participated in another clinical trial within 4&#xD;
             weeks prior to trial start.&#xD;
&#xD;
          3. Any disease of the lip and mouth that does not allow performing the lip measurement.&#xD;
&#xD;
          4. Diagnosis of any blood disorders affecting red blood cells ( aplastic anemia,&#xD;
             autoimmune hemolytic anemia, thalassemia)&#xD;
&#xD;
          5. Diagnosis of any blood disorders affecting white blood cells (lymphoma, multiple&#xD;
             myeloma, myeloplastic syndrome)&#xD;
&#xD;
          6. Diagnosis of any blood disorders affecting platelets ( idiopathic thrombocytopenic&#xD;
             purpura, primary thrombocythemia)&#xD;
&#xD;
          7. Diagnosis of blood plasma ( hemophilia, von Willebrand disease)&#xD;
&#xD;
          8. Diagnosis of acute or chronic inflammatory disease (respiratory tract, digestive tract&#xD;
             -bowel, liver, and any kidney disease)&#xD;
&#xD;
          9. Diagnosis of any neoplastic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Food and Nutrition Research Institute</name>
      <address>
        <city>Taguig</city>
        <state>Manila</state>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 4, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03749603
org study id: 18.10.DAI
nct id: NCT03749603
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Exploratory, interventional, one arm study
primary purpose: Diagnostic
masking: None (Open Label)
masking description: no masking required. assessments are both done on same subjects.
measure: Prevalence of Iron deficiency (ID stage I)
time frame: From Screening till study completion or up to 7 days, whichever comes first
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
measure: Prevalence of Iron deficient erythropoiesis (ID stage II)
time frame: From Screening till study completion or up to 7 days, whichever comes first
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
measure: Prevalence of iron deficiency anemia (ID stage III)
time frame: From Screening till study completion or up to 7 days, whichever comes first
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
measure: Prevalence of Anemia but no ID
time frame: From Screening till study completion or up to 7 days, whichever comes first
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
measure: 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
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
measure: 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
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
measure: 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
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
arm group label: TIBAY meter
arm group type: Experimental
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: TIBAY Meter
description: fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.
arm group label: TIBAY meter
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Philippines
responsible party type: Sponsor
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
sharing ipd: Undecided