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Not yet recruiting NCT07324135

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

No phase Interventional Iron Status

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nutritional product.
Who it may be relevant to
Registry conditions: Iron Status. Basic parameters: 12 months — 36 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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.

Interventions

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

Primary outcome measures

  • Serum ferritin concentration [Time frame: Baseline and 20 weeks post baseline]
Secondary outcome measures (1)
  • Daily iron intake [Time frame: Baseline, 10 weeks and 20 weeks post-baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

Indonesia · 1 center
  • Faculty of Medicine University of Indonesia — Jakarta

Identifiers

NCT: NCT07324135 · 24REX0077885

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗