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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-13

Study Completion Date

2026-01-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Iron Deficiency (ID) in Infants

NCT02484274

Iron Deficiency in Young Children Living in France

COMPLETED NA

EXPLorative Data Collection for Patient chAracterIzation, treatmeNt Pathways and Outcomes of IRON Preparations

NCT03382275

Iron-deficiency

COMPLETED

Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency

NCT06283342

Iron Deficiency Anemia in Childbirth Infant Nutrition Disorders Iron Deficiencies

COMPLETED

Efficacy of Iron Fortified Complementary Food and IPT of Malaria in Young Children in Côte d'Ivoire

NCT01634945

Anemia

COMPLETED NA

Different Efficacy of IFA Supplementation Among Obese and Non-obese Women

NCT06622551

Obesity and Overweight Anemia, Iron-Deficiency

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Iron Deficiencies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Standard blood test

Intervention Type DIAGNOSTIC_TEST

Blood test will measure haemoglobin and other parameters

Imaging and videography of anatomical sites

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard blood test

Blood test will measure haemoglobin and other parameters

Intervention Type DIAGNOSTIC_TEST

Imaging and videography of anatomical sites

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes