Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07324135

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine University of Indonesia

Jakarta, Indonesia

Location contact

Principal Investigator

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional product

Other

parents will be instructed to provide subjects with 2-3 servings of Study Product per day

Primary outcomes

  1. Serum ferritin concentration

    Time frame: Baseline and 20 weeks post baseline

Secondary outcomes

  1. Daily iron intake

    Time frame: Baseline, 10 weeks and 20 weeks post-baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Danone Global Research & Innovation Center (Nutricia Research)

CONTACT

[email protected]

+31 30 2095 000

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.