NCT07324135RecruitingNot Applicable
A Double-blind Randomized Controlled Study to Evaluate the Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.
Nutricia Research2 sites in 1 country466 target enrollmentStarted: March 13, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 466
- Locations
- 2
- Primary Endpoint
- Serum ferritin concentration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Months to 36 Months (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Control product
Other
Control: cow's milk
Intervention: Nutritional product (Other)
Test product
Experimental
Young Child Formula
Intervention: Nutritional product (Other)
Outcomes
Primary Outcomes
Serum ferritin concentration
Time Frame: Baseline and 20 weeks post baseline
Secondary Outcomes
- Daily iron intake(Baseline, 10 weeks and 20 weeks post-baseline)
Investigators
Study Sites (2)
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