Effect of Young Child Formula on Iron Status in 1- to 3-Year-Olds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares a test young child formula with a control product in children 1 to 3 years old. Participants will be assigned to receive either the test formula or a control product, with growth metrics, health data, parent diaries, and biological samples collected over the study period. Eligibility includes healthy children or those with mild anemia, regular milk consumption, and informed parental consent. Exclusion criteria include moderate to severe anemia, recent iron-related medications or infections, and conditions affecting iron metabolism. The study is conducted at the Faculty of Medicine, University of Indonesia, with Nutricia Research as the lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Faculty of Medicine University of Indonesia
  Jakarta, Indonesia Recruiting

Study contacts

• Study coordinator: Danone Global Research & Innovation Center (Nutricia Research)
• Email: register.clinicalresearchnutricia@danone.com
• Phone: +31 30 2095 000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.