A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children
NCT ID: NCT06577727
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2025-01-15
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children aged 6-72 months of age
Approximately 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.
Gold standard blood test
Blood test will measure haemoglobin and other parameters
Imaging and videography of anatomical sites
Images and videos of anatomical sites will be collected for AI to estimate iron status
Interventions
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Gold standard blood test
Blood test will measure haemoglobin and other parameters
Imaging and videography of anatomical sites
Images and videos of anatomical sites will be collected for AI to estimate iron status
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Parent(s) should have access to the internet and a smartphone or tablet to complete study questionnaires
4. Parent(s) should be able to comprehend the content of the study and complete the study questionnaires
5. Parents(s) must be comfortable with their child having blood draws
6. Subject has a Hb level corresponding to a Hb group with open slots for participation
Exclusion Criteria
2. 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).
3. Children who are unable to cooperate with study procedures.
4. Employees and/or children/family members or relatives of employees of Danone Global Research \&amp; Innovation Center or the participating sites.
6 Months
72 Months
ALL
Yes
Sponsors
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KK Women's and Children's Hospital
OTHER_GOV
Srinagarind Hospital, Khon Kaen University
OTHER
Danone Asia Pacific Holdings Pte, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Poh Choo Dr Khoo
Role: PRINCIPAL_INVESTIGATOR
KK Women's and Children's Hospital
Assoc.Prof. Suchaorn Saengnipanthkul
Role: PRINCIPAL_INVESTIGATOR
Srinagarind Hospital, Khon Kaen University, Khon Kaen
Locations
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KK Women's and Children's Hopsital
Singapore, , Singapore
Srinagarind Hospital, Khon Kaen University
Khon Kaen, , Thailand
Countries
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References
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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.
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.
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.
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.
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.
Tounian P, Chouraqui JP. [Iron in nutrition]. Arch Pediatr. 2017 May;24(5S):5S23-5S31. doi: 10.1016/S0929-693X(17)24006-8. French.
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.
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.
Other Identifiers
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EBB19GC28473 - A
Identifier Type: -
Identifier Source: org_study_id
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