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

NCT ID: NCT07324135

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

466 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, double-blind, parallel-group, multi-centre intervention study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test product

Young Child Formula

Group Type EXPERIMENTAL

Nutritional product

Intervention Type OTHER

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

Control product

Control: cow's milk

Group Type OTHER

Nutritional product

Intervention Type OTHER

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

Interventions

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Nutritional product

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutricia Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Medicine University of Indonesia

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

Central Contacts

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Danone Global Research & Innovation Center (Nutricia Research)

Role: CONTACT

+31 30 2095 000

Facility Contacts

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Principal Investigator

Role: primary

Other Identifiers

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24REX0077885

Identifier Type: -

Identifier Source: org_study_id

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