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

Nutricia

Status: Not yet enrolling

Conditions: Iron Status

Treatments: Other: Nutritional product

Study type: Interventional

Funder types: Industry

Identifiers

NCT07324135

24REX0077885

Details and patient eligibility

About

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.

Enrollment: 466 estimated patients

Sex: All

Ages: 12 to 36 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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466 participants in 2 patient groups

Test product

Experimental group

Description:

Young Child Formula

Treatment:

Other: Nutritional product

Control product

Other group

Description:

Control: cow's milk

Treatment:

Other: Nutritional product