ClinicalTrials.gg
CompletedNCT07186205FERROUS 3Updated Feb 4, 2026

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 in Iron Deficiencies, sponsored by Danone Asia Pacific Holdings Pte, Ltd.. Completed at 3 sites in Côte d’Ivoire. Open to participants aged 6 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Danone Asia Pacific Holdings Pte, Ltd. (part of Danone) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
126
Ages
6 Months to 6 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Iron Deficiencies

Keywords

  • Algorithm
  • Artificial Intelligence
  • Iron Deficiency
  • IDA
  • Anaemia
03

In context

Iron Deficiencies

386 studies on the registry are indexed under Iron Deficiencies; 80 are open to participants now.

This study's enrollment of 126 is below the median of 200 across 77 observational studies indexed under Iron Deficiencies.

Browse Iron Deficiencies studies →

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd. is the lead sponsor of 29 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children between 6 months to years of age

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 level corresponding to a haemoglobin group with open slots for participation.

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
126 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Diagnostic Test: Standard blood test · Other: Imaging and videography of anatomical sites

Interventions

  • Diagnostic testStandard blood test

    Blood test will measure haemoglobin and other parameters

  • OtherImaging and videography of anatomical sites

    Images and videos of anatomical sites will be collected to develop algorithms to estimate iron status

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: 2 days

Other outcomes

  1. Parental acceptability of the Iron digital tool

    Parental acceptability of the Iron digital tool assessed via the study questionnaire \[Accuracy, Usefulness, Frequency of usage, Data sharing\] on a scale of 1-5 (1 being the least acceptable and 5 being the most acceptable)

    Time frame: 1 day

  2. Investigator's (or delegates) acceptability of Iron digital tool

    Investigators (or delegates) likelihood of using the Iron digital tool assessed via the study questionnaire \[Ease of taking images/videos, accuracy, frequency of use, recommendation to parents\] on a scale of 1- 5 (1 being the least acceptable and 5 being the most acceptable)

    Time frame: 1 day

07

Study locations

3 sites
  • Hospital Center Régional D'abobo Félix Houphouët Boigny
    Abidjan, Côte d’Ivoire
  • Institut National de Sante Publique
    Abidjan, Côte d’Ivoire
  • Hôpital Mère Enfant Bingerville
    Bingerville, Côte d’Ivoire
08

References and documents

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 28622779 ↗
  • da 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 34564844 ↗
  • Lopez 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 26314490 ↗
  • Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015 May 7;372(19):1832-43. doi: 10.1056/NEJMra1401038. No abstract available. PubMed 25946282 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07186205
Collaborators
Institut National de Sante Publique, Hospital Center Régional D'abobo Félix Houphouët Boigny, Hôpital Mère Enfant Bingerville
Responsible party
Sponsor
First posted
Sep 22, 2025
Start date
Oct 13, 2025
Primary completion
Jan 9, 2026
Completion
Jan 9, 2026
Last update
Feb 4, 2026

Study contacts

Amed Coulibaly, MBBS
principal investigator · Institut National de Santé Publique (INSP)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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