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Recruiting
NCT07324135
Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.
Conditions: Iron Status
Sex: All
Ages: 12 Months – 36 Months
Healthy volunteers: Yes
Phase: NA
Enrollment: 466
Sponsor: Nutricia Research
Location: Faculty of Medicine University of Indonesia Jakarta
Summary
This study evaluates the effect of young child formula in children 1-3 years of age. Subjects will receive either test or control product. Growth and health data, parent diaries and biological samples will be collected during the study.
Eligibility Criteria
Inclusion Criteria:
* Children aged 1 to 3 years
* Healthy children (as per investigator clinical judgement and non-anaemic as confirmed by Hb levels) or meeting the criteria for mild anaemia based on Hb levels
* Children familiar with drinking milk products (in combination with breastfeeding or not) for at least 3 weeks prior to screening.
* Written informed consent provided by parent(s) / legally acceptable representative(s) aged ≥18 years at screening
Exclusion Criteria:
* Low Hb meeting the criteria for moderate or severe anaemia
* Use of iron and/or fibre supplementation within 3 months prior to screening
* Any infection within 2 weeks prior to screening
* Any other medical condition with known high CRP (\>5 mg/L) / high AGP (\>1 g/L) value within 2 weeks prior to screening
* The use of medication that is likely to interfere with iron metabolism) within 2 weeks prior to screening
* The use of medication to treat iron deficiency or anaemia within 3 months prior to screening
* Any developmental delays that could impact feeding behaviour or growth, or any other condition that is likely to influence nutritional status or growth.
* Disorders requiring a special diet.
* Any other iron metabolism and related disorders
* Children with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances.
Source: ClinicalTrials.gov (NCT07324135). StuddyBuddy aggregates publicly available trial information.