Iron Status
Conditions
Keywords
YCF, Young Child Formula, Anaemia, Iron status
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.
Interventions
OTHERNutritional product
parents will be instructed to provide subjects with 2-3 servings of Study Product per day
Sponsors
Nutricia Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective, randomized, double-blind, parallel-group, multi-centre intervention study
Eligibility
Sex/Gender
ALL
Age
12 Months to 36 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum ferritin concentration | Baseline and 20 weeks post baseline |
Secondary
| Measure | Time frame |
|---|---|
| Daily iron intake | Baseline, 10 weeks and 20 weeks post-baseline |
Countries
Indonesia
Contacts
CONTACTDanone Global Research & Innovation Center (Nutricia Research)
Outcome results
None listed