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

Not Applicable

Completed

• Conditions: Nutritional Status; Child Nutrition Sciences; Toddlers
• Interventions: Other: Fortified milk

• Registration Number: NCT05440604
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-06-23
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-07-01
• Primary Completion: 2022-12-14
• Study Completion: 2022-12-14
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

1. Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent.
2. 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
3. Age 3 years old to 4 years old and 6 months at enrolment
4. 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
5. 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
6. 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
7. Child's parent(s)/guardian can be contacted directly by telephone or mobile phone throughout the study

Exclusion Criteria

1. Chronic infectious, metabolic, genetic illness, or other disease including any condition that impacts feeding, or any outcome measures
2. Child exhibits any clinical signs of potential micronutrient deficiencies (e.g., hemoglobin < 100 g/L based on screening assessment, rickets based on physical exam).
3. Known or suspected cows' milk protein intolerance / lactose intolerance /allergy or severe food allergies that impact diet
4. Breast milk used exclusively / mixed in place of all other milk, and/or milk alternatives at 3 years of age
5. Consuming supplement(s) of relevance to the study outcome relating diet to status, vitamins A, D, E and C; zinc
6. Child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fortified milk group	Fortified milk	2 daily servings of the investigational fortified milk for 16 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Las Piñas Doctors Hospital; 🇵🇭 Las Piñas, Metro Manila, Philippines