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

NCT07186205 | Completed

• 1 other identifier: 24REX0083183
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Iron Deficiencies

Keywords

Algorithm; Artificial Intelligence; Iron Deficiency; IDA; Anaemia

Outcome Measures

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

  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

  2 days

Other Outcomes (2)

• Parental acceptability of the Iron digital tool

  1 day

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

  1 day

Study Arms (1)

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

Standard blood test DIAGNOSTIC_TEST

Blood test will measure haemoglobin and other parameters

Children aged 6-72 months of age

Imaging and videography of anatomical sites OTHER

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

Children aged 6-72 months of age

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children between 6 months to years of age

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead
• Institut National de Sante Publique: collaborator
• Hospital Center Régional D'abobo Félix Houphouët Boigny: collaborator
• Hôpital Mère Enfant Bingerville: collaborator

Study Sites (3)

Hospital Center Régional D'abobo Félix Houphouët Boigny

Abidjan, Côte d’Ivoire

Location

Institut National de Sante Publique

Abidjan, Côte d’Ivoire

Location

Hôpital Mère Enfant Bingerville

Bingerville, Côte d’Ivoire

Location

Related Publications (4)

• Tounian P, Chouraqui JP. [Iron in nutrition]. Arch Pediatr. 2017 May;24(5S):5S23-5S31. doi: 10.1016/S0929-693X(17)24006-8. French.

  PMID: 28622779 BACKGROUND

• 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.

  PMID: 34564844 BACKGROUND

• 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.

  PMID: 26314490 BACKGROUND

• Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015 May 7;372(19):1832-43. doi: 10.1056/NEJMra1401038. No abstract available.

  PMID: 25946282 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies; Anemia

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Amed Coulibaly, MBBS

  Institut National de Santé Publique (INSP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 22, 2025
• Study Start: October 13, 2025
• Primary Completion: January 9, 2026
• Study Completion: January 9, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CÔ (3)