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Recruiting NCT07324135

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

Conditions: Iron Status

Sex: All
Ages: 12 Months – 36 Months
Healthy volunteers: Yes
Phase: NA
Enrollment: 466
Sponsor: Nutricia Research

Location: Faculty of Medicine University of Indonesia Jakarta

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07324135). StuddyBuddy aggregates publicly available trial information.