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

Not yet recruiting

• Conditions: Iron Deficiencies

• Registration Number: NCT07186205
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-07
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-21
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-25
• Study Start: 2025-10-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

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