Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.
ConditionIron Status
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-36
SponsorNutricia Research
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nutritional product
Other interventionparents will be instructed to provide subjects with 2-3 servings of Study Product per day
Treatment groups
466 Participants
are divided into 2 treatment groupsGroup A: Test productExperimental treatment 1 intervention
Group B: Control productOther 1 intervention
Trial outcomes
Primary outcomes
1
Serum ferritin concentration
Time frame
Baseline and 20 weeks post baselineSecondary outcomes
1
Daily iron intake
Time frame
Baseline, 10 weeks and 20 weeks post-baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov