Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749603
Recruitment Status : Completed
First Posted : November 21, 2018
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Nestlé

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.

Condition or disease Intervention/treatment Phase
Iron-deficiency Iron Deficiency Anemia Anemia Device: TIBAY Meter Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1521 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Exploratory, interventional, one arm study
Masking: None (Open Label)
Masking Description: no masking required. assessments are both done on same subjects.
Primary Purpose: Diagnostic
Official Title: A Study Assessing Iron Status and Anemia in Filipino School Children From MIMAROPA Region
Actual Study Start Date : January 14, 2019
Actual Primary Completion Date : May 20, 2019
Actual Study Completion Date : May 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749603


Locations
Layout table for location information
Philippines
Food and Nutrition Research Institute
Taguig, Manila, Philippines
Sponsors and Collaborators
Nestlé
Layout table for additonal information
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03749603    
Other Study ID Numbers: 18.10.DAI
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases