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Completed

NCT Number: NCT07186205

A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Risk of Iron Deficiency and Anaemia in African Children

An exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in African children

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Key information

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Center Régional D'abobo Félix Houphouët Boigny, Abidjan, Côte d’Ivoire

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

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

Treatment and study plan

Standard blood test

Diagnostic Test

Blood test will measure haemoglobin and other parameters

Imaging and videography of anatomical sites

Other

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

Primary outcomes

  1. 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

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

    Time frame: 2 days

    Correlation Coefficient will be calculated to measure the strength and direction of association between iron intake estimated by IronQ and the 24-hour recall.

Other outcomes

  1. Parental acceptability of the Iron digital tool

    Time frame: 1 day

    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)

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

    Time frame: 1 day

    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)

Sponsors and collaborators

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Industry

Collaborators

  • Hospital Center Régional D'abobo Félix Houphouët Boigny
  • Hôpital Mère Enfant Bingerville
  • Institut National de Sante Publique

Registry information

Acronym: FERROUS 3

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
Feb 4, 2026

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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