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

December 23, 2025 updated by: Nutricia Research

A Double-blind Randomized Controlled Study to Evaluate the 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

466

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Faculty of Medicine University of Indonesia
        • Contact:
          • Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test product
Young Child Formula
Other: Nutritional product
parents will be instructed to provide subjects with 2-3 servings of Study Product per day
Other: Control product
Control: cow's milk
Other: Nutritional product
parents will be instructed to provide subjects with 2-3 servings of Study Product per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum ferritin concentration
Time Frame: Baseline and 20 weeks post baseline
Baseline and 20 weeks post baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Daily iron intake
Time Frame: Baseline, 10 weeks and 20 weeks post-baseline
Baseline, 10 weeks and 20 weeks post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutricia Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24REX0077885

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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