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NCT Number: NCT03749603

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

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.

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food and Nutrition Research Institute

City of Taguig, Manila, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIBAY Meter

Device

fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2018
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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