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

NCT07324135 | Not Yet Recruiting

• 1 other identifier: 24REX0077885
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron Status

Keywords

YCF; Young Child Formula; Anaemia; Iron status

Outcome Measures

Primary Outcomes (1)

• Serum ferritin concentration

  Baseline and 20 weeks post baseline

Secondary Outcomes (1)

• Daily iron intake

  Baseline, 10 weeks and 20 weeks post-baseline

Study Arms (2)

Test product

EXPERIMENTAL

Young Child Formula

Other: Nutritional product

Control product

OTHER

Control: cow's milk

Other: Nutritional product

Interventions

Nutritional product OTHER

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

Control product; Test product

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

Faculty of Medicine University of Indonesia

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Danone Global Research & Innovation Center (Nutricia Research)

CONTACT

+31 30 2095 000; register.clinicalresearchnutricia@danone.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double-blind, parallel-group, multi-centre intervention study

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)