Nutrient and Immunity Status in Children Aged 3-5 Years Consuming Their Habitual Diet With or Without Fortified Milk

Study Overview
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Brief Summary
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This study compares the status of key micronutrients (vitamins A, C, D, E, and zinc) in young children given investigational fortified milk versus young children consuming their habitual pattern of beverage intake (milk and non-milk beverages).

Detailed Description
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Hypothesis that Vitamin A, C, D, E and zinc status of children consuming 2 servings / day of fortified milk for 16 weeks will be better than those of children consuming their habitual pattern of beverage intake (milk and non-milk beverages, juices, sugar-sweetened drinks) for the same duration. This is based on previous study findings that (i) the toddler's and preschooler's diet, in reality, are often not optimal, putting toddlers and preschool age children at risk of insufficient intakes of several nutrients, and (ii) consuming fortified milk supplemented with these nutrients might provide optimal intakes of these nutrients.

Official Title
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Nutrient and Immunity Status in Children Aged 3-5 Years Consuming Their Habitual Diet With or Without Fortified Milk

Conditions
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Nutritional Status, Child Nutrition Sciences, Toddlers

Intervention / Treatment
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* Other: Fortified milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent. Child's parent(s)/guardian is/are of legal age of consent, must understand the informed consent and other study documents, and is/are willing and able to fulfill the requirements of the study protocol Age 3 years old to 4 years old and 6 months at enrolment Healthy at birth, singleton, full-term gestational birth (37-42 completed weeks of gestation), with a birth weight of 2.5 kg to 3.9 kg At the time of enrolment, the participant's weight-for-age, height-for-age, weight-for-height, BMI z-score should be within -2 to +1 At the time of enrolment, the participant is in good health (no history of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the child to ingest food, the normal growth and development of the child, or the evaluation of the infant; acute illness in a minor condition which are common in childhood such as viral or bacterial infection e.g. conjunctivitis, otitis media, upper/lower respiratory tract infection, gastroenteritis, hand foot & mouth disease at time of enrolment is permitted) as determined by physical history, physical exam and judgement by the investigator Child's parent(s)/guardian can be contacted directly by telephone or mobile phone throughout the study Exclusion Criteria: Chronic infectious, metabolic, genetic illness, or other disease including any condition that impacts feeding, or any outcome measures Child exhibits any clinical signs of potential micronutrient deficiencies (e.g., hemoglobin < 100 g/L based on screening assessment, rickets based on physical exam). Known or suspected cows' milk protein intolerance / lactose intolerance /allergy or severe food allergies that impact diet Breast milk used exclusively / mixed in place of all other milk, and/or milk alternatives at 3 years of age Consuming supplement(s) of relevance to the study outcome relating diet to status, vitamins A, D, E and C; zinc Child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 54 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fortified milk group<br>2 daily servings of the investigational fortified milk for 16 weeks | Other: Fortified milk<br>* Commercially available milk-based fortified beverage that has an updated profile of key micronutrients along with appropriate levels of protein and other macro- and micro- nutrients, in accordance with global and local nutritional recommendations<br>|
| No Intervention: Observational group<br>will be asked to consume beverages in accordance with their habitual pattern of intake | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in vitamin A status | measure in serum retinol in μmol/L | 16 weeks | 
| change in vitamin C status | measure in plasma vitamin C in mg/dL | 16 weeks | 
| change in vitamin D status | measure in serum 25-hydroxy vitamin D (25[OH]D) in nmol/L | 16 weeks | 
| change in vitamin E status | measure in plasma alpha-tocopherol in mg/L | 16 weeks | 
| change in zinc status | measure in plasma zinc in μg/dl | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monitor growth and development | anthropometry assessment measured by weight (kg) | 16 weeks | 
| monitor growth and development | anthropometry assessment measured by height (cm) | 16 weeks | 
| monitor growth and development | anthropometry assessment measured by BMI (kg/m^2) | 16 weeks | 
| assess dietary intake | using a 24-hour Dietary Recall completed by the parent / caregiver | 4 weeks, 8 weeks, 12 weeks, 16 weeks | 
| assess habitual pattern of food and beverage intake | using a semi-quantitative food frequency questionnaire completed by the parent / caregiver | 16 weeks | 
| assess child developmental milestones | using Laban Quotient to assess physical, social, self-help and cognitive; minimum score 1 , maximum 5; higher scores indicate more positive outcomes | 16 weeks | 
| assess fortified milk acceptability | using Milk Intake Diary for interventional group completed by the parent / caregiver | 4 weeks, 8 weeks, 12 weeks, 16 weeks | 
| nucleotides status assessment | measure concentration of nucleotides | 16 weeks | 
| monitor standard adverse events (AE) | safety assessment by monitoring the AEs linked with participation in study | 16 weeks | 
| monitor absenteeism from day care or pre-school due to illness | safety assessment by monitoring the days of absenteeism linked with participation in study | 16 weeks | 
| monitor concomitant medication (CM) reporting | safety assessment by monitoring number of participants that took concomitant medication linked with participation in study | 16 weeks |