Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.

NCT07324135 — Not applicable, Recruiting, 466 participants, Nutricia Research

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

A Double-blind Randomized Controlled Study to Evaluate the Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.

RegistryNCT07324135
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, basic science
Enrollment466 (Estimated)
SponsorNutricia Research (Industry)
ConditionsIron Status
InterventionsNutritional product (Other)
Datesstart 2026-03-13, primary completion 2026-12-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-01-07, last updated 2026-09-01
Locations1 site in Indonesia

Related Papers Related Patents Related Grants Related Experts
All trials for Iron Status All trials of Nutritional product

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Test productExperimentalOther: Nutritional productYoung Child Formula
Control productOtherOther: Nutritional productControl: cow's milk
  • Nutritional product (Other): parents will be instructed to provide subjects with 2-3 servings of Study Product per day

+Outcome measures

Primary outcomes

  • Serum ferritin concentration [Baseline and 20 weeks post baseline]

Secondary outcomes

  • Daily iron intake [Baseline, 10 weeks and 20 weeks post-baseline]

+Eligibility

Sex: All, ages: 12 Months to 36 Months, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Faculty of Medicine University of IndonesiaJakartaIndonesiaRecruiting