AzTrials
AzTrials

Iron DeficiencyFERROUS 2NCT06577727

A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children

An observational study of Iron Deficiency, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

An exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in children Read more about this study

Who is it for?
Ages 6 to 72 monthsHealthy volunteers can take part
Conditions the study is for
Iron Deficiency
What is being tested?
Gold standard blood test and Imaging and videography of anatomical sites
How many people
250 participants
Where
2 sitesin 2 countries
Study dates
15 Jan 2025to 30 Sep 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 72 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children between 6 to 72 months of age

Who may be able to join

  • Children above 6 months of age and below 6 years of age
  • Written consent from parent(s) or legally acceptable representative(s), who themselves are aged ≥ 21 years old, to consent and comply with the terms and conditions of the study
  • Parent(s) should have access to the internet and a smartphone or tablet to complete study questionnaires
  • Parent(s) should be able to comprehend the content of the study and complete the study questionnaires
  • Parents(s) must be comfortable with their child having blood draws
  • Subject has a Hb level corresponding to a Hb group with open slots for participation

Who cannot join

  • Children with any medical condition that in the opinion of the investigator would not be suitable for enrolment.
  • Children with nail bed obstructions, nail polish, nails discolouration (e.g., leukonychia, melanonychia, bruising, etc.), or scarring of the lips, pigmentations on lips for thyroid dysfunction (e.g., Puettz-jeghers syndrome).
  • Children who are unable to cooperate with study procedures.
  • Employees and/or children/family members or relatives of employees of Danone Global Research \& Innovation Center or the participating sites.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Singapore1 site

  • KK Women's and Children's Hopsital

    Singapore

Other trials in Singapore

Thailand1 site

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen

Other trials in Thailand

About this study

Official title: A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children (FERROUS 2)

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

Read the 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 gold 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
Iron Deficiency
Being tested
Gold standard blood test, Imaging and videography of anatomical sites
Keywords
Algorithm, Artificial Intelligence, Iron Deficiency, IDA, Anemia
Medical subject headings
Iron Deficiencies, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gold standard blood testOther

    Blood test will measure haemoglobin and other parameters

  • Imaging and videography of anatomical sitesOther

    Images and videos of anatomical sites will be collected for AI to estimate iron status

Study groups in NCT06577727
Study groupRoleWhat they receive
Children aged 6-72 months of ageApproximately 250 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. There will be a minimum of 10 subjects and a maximum of 25 subjects for each group.
Receives: Other: Gold standard blood test; Other: Imaging and videography of anatomical sites

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of the Iron AI in a clinic setting

    Accuracy of the Iron Ai in a clinic setting, derived from:

    1. The Iron AI prediction from images/videos collected
    2. The gold standard blood test results

    Measured: 1 day

Secondary outcomes (2)

  1. Parental acceptability of the Iron AI

    Parental acceptability of the Iron AI assessed via the study questionnaire [Accuracy, Usefulness, Frequency of usage, Data sharing]

    Measured: 1 day

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

    Investigators (or delegates) likelihood of using the Iron AI assessed via the study questionnaire [Ease of taking images/videos, accuracy, frequency of use, recommendation to parents]

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2024
  2. Study start15 Jan 2025
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06577727
Sponsor's protocol ID
EBB19GC28473 - A
Acronym
FERROUS 2
Status last verified
Feb 2026
First submitted
27 Aug 2024
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baker RD, Greer FR; Committee on Nutrition American Academy of Pediatrics. Diagnosis and prevention of iron deficiency and iron-deficiency anemia in infants and young children (0-3 years of age). Pediatrics. 2010 Nov;126(5):1040-50. doi: 10.1542/peds.2010-2576. Epub 2010 Oct 5.

    PubMed 20923825

  • 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.

    PubMed 26314490

  • Khedr E, Hamed SA, Elbeih E, El-Shereef H, Ahmad Y, Ahmed S. Iron states and cognitive abilities in young adults: neuropsychological and neurophysiological assessment. Eur Arch Psychiatry Clin Neurosci. 2008 Dec;258(8):489-96. doi: 10.1007/s00406-008-0822-y. Epub 2008 Jun 20.

    PubMed 18574611

  • WHO (2008) Worldwide prevalence of anaemia 1993-2005. In: de Benoist B, McLean E, Egli I, Cogswell M, editors. WHO global database on anaemia. Geneva: World Health Organization.

  • WHO (2001) Iron deficiency anaemia. Assessment, prevention, and control. A guide for programme managers. Geneva: World Health Organization.

  • Anaemia in women and children (2021). World Health Organization. https://www.who.int/data/gho/data/themes/topics/anaemia_in_women_and_children?utm_content=buffer85683&utm

  • Saarinen UM, Siimes MA, Dallman PR. Iron absorption in infants: high bioavailability of breast milk iron as indicated by the extrinsic tag method of iron absorption and by the concentration of serum ferritin. J Pediatr. 1977 Jul;91(1):36-9. doi: 10.1016/s0022-3476(77)80439-3.

    PubMed 577504

  • 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.

    PubMed 34564844

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

    PubMed 28622779

  • Vitamin and mineral requirements in human nutrition, Second edition, World Health Organization and Food and Agriculture Organization of the United Nations, 2004.

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

    PubMed 25946282

  • Kohli-Kumar M. Screening for anemia in children: AAP recommendations--a critique. Pediatrics. 2001 Sep;108(3):E56. doi: 10.1542/peds.108.3.e56.

    PubMed 11533374

Questions about this trial

What is this clinical trial studying?

An observational study of Iron Deficiency, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of the Iron AI in a clinic setting (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06577727, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in