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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07186205

Acronym

FERROUS 3

Enrollment

126

Registered

2025-09-22

Start date

2025-10-13

Completion date

2026-01-09

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiencies

Keywords

Algorithm, Artificial Intelligence, Iron Deficiency, IDA, Anaemia

Brief summary

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.

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 6 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of the Iron digital tool in estimating hemoglobin level as compared to standard blood test.	1 day	Mean absolute error (MAE), Mean Absolute Percentage Error (MAPE) and Mean Square Error (MSE) will be calculated for accuracy

Secondary

Measure	Time frame	Description
To evaluate Iron Questionnaire (IronQ)'s performance in estimating risk of iron intake deficiency as compared to dietary intake from 24-hour recall diary	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.

Countries

Côte d’Ivoire

Contacts

PRINCIPAL_INVESTIGATORAmed Coulibaly, MBBS

Institut National de Santé Publique (INSP)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026