Iron DeficienciesFERROUS 3NCT07186205
A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Risk of Iron Deficiency and Anaemia in African Children
An observational study of Iron Deficiencies, run by Danone Asia Pacific Holdings Pte, Ltd. at 3 sites in Côte d’Ivoire.
Trial summary
An exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in African children Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiencies
- What is being tested?
- Standard blood test and Imaging and videography of anatomical sites
- How many people
- 126 participants
- Where
- 3 sitesCôte d’Ivoire
- Study dates
- 13 Oct 2025to 9 Jan 2026
- Phase
- Observational
- 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 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children between 6 months to years of age
Who may be able to join
- Children over 6 months of age and under 6 years of age.
- Written consent from the legally acceptable parent(s) or representative(s), who are themselves ≥ 18 years of age, to consent to and comply with the terms and conditions of the study.
- The parent(s) must be able to understand the content of the study and complete the study questionnaires.
- Parents should be comfortable with their child having blood drawn.
- The participant must have a haemoglobin level corresponding to a haemoglobin group with open slots for participation.
Who cannot join
- Children with a medical condition that, in the opinion of the investigator, would render them unsuitable for enrolment
- Children with nail bed obstructions, nail polish, nail discoloration (e.g., leukonychia, melanonychia, bruising, etc.), or scarring of the lips, or lip pigmentation due to thyroid dysfunction (e.g., Peutz-Jeghers syndrome)
- Children who are unable to cooperate with study procedures
- Employees and/or children/family members or parents of employees of the Danone Global Research \& Innovation Center or Danone affiliates participating sites
- Children whose health condition requires emergency care
Trial locations and contacts
3 sites in 1 country.
Côte d’Ivoire3 sites
Hospital Center Régional D'abobo Félix Houphouët Boigny
Abidjan
Institut National de Sante Publique
Abidjan
Hôpital Mère Enfant Bingerville
Bingerville
About this study
An exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in African children
Read the detailed description
This is an exploratory, observational, pilot study that aims to build and measure the accuracy of an algorithm that estimates a child's iron status using images and/or videos, against standard venous blood sampling. Images and/or videos will be collected by healthcare professionals, together with blood test results. This data will be used to evaluate the accuracy of the algorithm and to explore potential improvements. Data on the acceptance and experience of the using the algorithm will be collected for improvements.
- Conditions
- Iron Deficiencies
- Being tested
- Standard blood test, Imaging and videography of anatomical sites
- Keywords
- Algorithm, Artificial Intelligence, Iron Deficiency, IDA, Anaemia
- Medical subject headings
- Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard blood testDiagnostic test
Blood test will measure haemoglobin and other parameters
Imaging and videography of anatomical sitesOther
Images and videos of anatomical sites will be collected to develop algorithms to estimate iron status
| Study group | Role | What they receive |
|---|---|---|
| Children aged 6-72 months of age | Approximately 120 children aged above 6 months old and below 6 years of age across potential study sites. Subjects will be grouped by haemoglobin (Hb) level ranging from <6 g/dL to ≥ 14.0 g/dL. Receives: Diagnostic Test: Standard blood test; Other: Imaging and videography of anatomical sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the Iron digital tool in estimating hemoglobin level as compared to standard blood test.
Mean absolute error (MAE), Mean Absolute Percentage Error (MAPE) and Mean Square Error (MSE) will be calculated for accuracy
Measured: 1 day
Secondary outcomes (1)
To evaluate Iron Questionnaire (IronQ)'s performance in estimating risk of iron intake deficiency as compared to dietary intake from 24-hour recall diary
Correlation Coefficient will be calculated to measure the strength and direction of association between iron intake estimated by IronQ and the 24-hour recall.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start13 Oct 2025
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut National de Sante Publique, Hospital Center Régional D'abobo Félix Houphouët Boigny, Hôpital Mère Enfant Bingerville
- Responsible party
- Sponsor
- Investigators
- Amed Coulibaly, MBBS, Principal investigator, Institut National de Santé Publique (INSP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186205
- Sponsor's protocol ID
- 24REX0083183
- Acronym
- FERROUS 3
- Status last verified
- Feb 2026
- First submitted
- 7 Sep 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tounian P, Chouraqui JP. [Iron in nutrition]. Arch Pediatr. 2017 May;24(5S):5S23-5S31. doi: 10.1016/S0929-693X(17)24006-8. French.
PubMed 28622779da Silva Lopes K, Yamaji N, Rahman MO, Suto M, Takemoto Y, Garcia-Casal MN, Ota E. Nutrition-specific interventions for preventing and controlling anaemia throughout the life cycle: an overview of systematic reviews. Cochrane Database Syst Rev. 2021 Sep 26;9(9):CD013092. doi: 10.1002/14651858.CD013092.pub2.
PubMed 34564844Lopez A, Cacoub P, Macdougall IC, Peyrin-Biroulet L. Iron deficiency anaemia. Lancet. 2016 Feb 27;387(10021):907-16. doi: 10.1016/S0140-6736(15)60865-0. Epub 2015 Aug 24.
PubMed 26314490Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015 May 7;372(19):1832-43. doi: 10.1056/NEJMra1401038. No abstract available.
PubMed 25946282
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Risk of Iron Deficiency and Anaemia in African Children
- ClinicalTrials.gov ID
- NCT07186205
- Acronym / sponsor ID
- FERROUS 3 / 24REX0083183
- Conditions
- Iron Deficiencies
- Keywords
- Algorithm, Artificial Intelligence, Iron Deficiency, IDA, Anaemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Institut National de Sante Publique, Hospital Center Régional D'abobo Félix Houphouët Boigny, Hôpital Mère Enfant Bingerville
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 22 Sep 2025 (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.
An exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in African children
Detailed description
This is an exploratory, observational, pilot study that aims to build and measure the accuracy of an algorithm that estimates a child's iron status using images and/or videos, against standard venous blood sampling. Images and/or videos will be collected by healthcare professionals, together with blood test results. This data will be used to evaluate the accuracy of the algorithm and to explore potential improvements. Data on the acceptance and experience of the using the algorithm will be collected for improvements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children aged 6-72 months of age | – | Diagnostic Test: Standard blood test, Other: Imaging and videography of anatomical sitesApproximately 120 children aged above 6 months old and below 6 years of age across potential study sites. Subjects will be grouped by haemoglobin (Hb) level ranging from <6 g/dL to ≥ 14.0 g/dL. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children between 6 months to years of age
Key inclusion criteria (5 listed)
- Children over 6 months of age and under 6 years of age.
- Written consent from the legally acceptable parent(s) or representative(s), who are themselves ≥ 18 years of age, to consent to and comply with the terms and conditions of the study.
- The parent(s) must be able to understand the content of the study and complete the study questionnaires.
- Parents should be comfortable with their child having blood drawn.
- The participant must have a haemoglobin level corresponding to a haemoglobin group with open slots for participation.
Key exclusion criteria (5 listed)
- Children with a medical condition that, in the opinion of the investigator, would render them unsuitable for enrolment
- Children with nail bed obstructions, nail polish, nail discoloration (e.g., leukonychia, melanonychia, bruising, etc.), or scarring of the lips, or lip pigmentation due to thyroid dysfunction (e.g., Peutz-Jeghers syndrome)
- Children who are unable to cooperate with study procedures
- Employees and/or children/family members or parents of employees of the Danone Global Research \& Innovation Center or Danone affiliates participating sites
- Children whose health condition requires emergency care
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 |
|---|---|---|
| Standard blood testBlood test will measure haemoglobin and other parameters | Diagnostic test | Children aged 6-72 months of age |
| Imaging and videography of anatomical sitesImages and videos of anatomical sites will be collected to develop algorithms to estimate iron status | Other | Children aged 6-72 months of age |
Primary outcome
Accuracy of the Iron digital tool in estimating hemoglobin level as compared to standard blood test.
Time frame: 1 day
Mean absolute error (MAE), Mean Absolute Percentage Error (MAPE) and Mean Square Error (MSE) will be calculated for accuracy
1 secondary outcome
To evaluate Iron Questionnaire (IronQ)'s performance in estimating risk of iron intake deficiency as compared to dietary intake from 24-hour recall diary
Time frame: 2 days
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 4 Feb 2026.
- Background: PubMed 28622779Tounian P, Chouraqui JP. [Iron in nutrition]. Arch Pediatr. 2017 May;24(5S):5S23-5S31. doi: 10.1016/S0929-693X(17)24006-8. French.
- Background: PubMed 34564844da Silva Lopes K, Yamaji N, Rahman MO, Suto M, Takemoto Y, Garcia-Casal MN, Ota E. Nutrition-specific interventions for preventing and controlling anaemia throughout the life cycle: an overview of systematic reviews. Cochrane Database Syst Rev. 2021 Sep 26;9(9):CD013092. doi: 10.1002/14651858.CD013092.pub2.
- Background: PubMed 26314490Lopez A, Cacoub P, Macdougall IC, Peyrin-Biroulet L. Iron deficiency anaemia. Lancet. 2016 Feb 27;387(10021):907-16. doi: 10.1016/S0140-6736(15)60865-0. Epub 2015 Aug 24.
- Background: PubMed 25946282Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015 May 7;372(19):1832-43. doi: 10.1056/NEJMra1401038. No abstract available.
- Individual participant dataSharing planned: No
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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.
Amed Coulibaly, MBBS principal investigator
Institut National de Santé Publique (INSP)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiencies, run by Danone Asia Pacific Holdings Pte, Ltd. at 3 sites in Côte d’Ivoire.
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 5 inclusion and 5 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Côte d’Ivoire. 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?
Accuracy of the Iron digital tool in estimating hemoglobin level as compared to standard blood test. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07186205, which also lists 4 linked publications.
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 4 Feb 2026.