Iron-deficiencyNCT03749603
A Study Assessing Iron Status and Anemia in Filipino School Children From MIMAROPA Region
A study testing TIBAY Meter in people with Iron-deficiency and Iron Deficiency Anemia, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia, Anemia
- What is being tested?
- TIBAY Meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,521 participants
- Where
- 1 sitePhilippines
- Study dates
- 14 Jan 2019to 20 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 6 - 11 years old
- Having obtained his/her informed assent.
- Informed consent signed by one parent or legal authorized representative if applicable.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Food and Nutrition Research Institute
City of Taguig, Manila
About this study
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.
Read the 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.
- Conditions
- Iron-deficiency, Iron Deficiency Anemia, Anemia
- Being tested
- TIBAY Meter
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIBAY MeterDevice
fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TIBAY Meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
Measured: From Screening till study completion or up to 7 days, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start14 Jan 2019
- Primary completion20 May 2019
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory, interventional, one arm study
- Masking
- None (open label)
- Enrolment
- 1,521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749603
- Sponsor's protocol ID
- 18.10.DAI
- Status last verified
- Mar 2023
- First submitted
- 4 Oct 2018
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing Iron Status and Anemia in Filipino School Children From MIMAROPA Region
- ClinicalTrials.gov ID
- NCT03749603
- Acronym / sponsor ID
- 18.10.DAI
- Conditions
- Iron-deficiency, Iron Deficiency Anemia, Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,521 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory, interventional, one arm study
| Arm | Type | Receives |
|---|---|---|
| TIBAY meter | Experimental | Device: TIBAY MeterNon-invasive measurement of red blood cell Zinc Protoporphyrin (ZnPP/haem ratio-µmol/mol haem) fluorescence in the microcirculation of the lower lip. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 6 - 11 years old
- Having obtained his/her informed assent.
- Informed consent signed by one parent or legal authorized representative if applicable.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIBAY Meterfluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip. | Device | TIBAY meter |
Primary outcome
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
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
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
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
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Iron-deficiency
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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
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Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
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RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIBAY Meter in people with Iron-deficiency and Iron Deficiency Anemia, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Iron deficiency (ID stage I) (time frame: From Screening till study completion or up to 7 days, whichever comes first). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.