Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age. (NCT07324135) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.
Indonesia466 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range12 Months – 36 Months
SexALL
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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.
What they're measuring
1
Serum ferritin concentration
Timeframe: Baseline and 20 weeks post baseline
Trial details
NCT IDNCT07324135
SponsorNutricia Research
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2026-12
Contact for this trial
Danone Global Research & Innovation Center (Nutricia Research)