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

NCT03749603 | Completed

• 1 other identifier: 18.10.DAI
• Study Type: interventional
• Target: 1,521
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron-deficiency; Iron Deficiency Anemia; Anemia

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Comparison the non-invasive ZnPP with other standard blood iron status measurements

  From Screening till study completion or up to 7 days, whichever comes first

Study Arms (1)

TIBAY meter

EXPERIMENTAL

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

Interventions

TIBAY Meter DEVICE

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

TIBAY meter

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age between 6 - 11 years old
• Having obtained his/her informed assent.
• Informed consent signed by one parent or legal authorized representative if applicable.

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Food and Nutrition Research Institute

City of Taguig, Manila, Philippines

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking required. assessments are both done on same subjects.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Exploratory, interventional, one arm study

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: November 21, 2018
• Study Start: January 14, 2019
• Primary Completion: May 20, 2019
• Study Completion: May 20, 2019
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

PH (1)