Clinical trial NCT05440604: Nutrient and Immunity Status in Children Aged 3-5 Years Consuming Their Habitual Diet With or Without Fortified Milk
Official title: Nutrient and Immunity Status in Children Aged 3-5 Years Consuming Their Habitual Diet With or Without Fortified Milk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Status
Child Nutrition Sciences
Toddlers
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2022-07-01
Enrollment: 112
Sex: ALL
Minimum age (years): 36
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in vitamin A status
timeFrame: 16 weeks
measure: change in vitamin C status
timeFrame: 16 weeks
measure: change in vitamin D status
timeFrame: 16 weeks
measure: change in vitamin E status
timeFrame: 16 weeks
measure: change in zinc status
timeFrame: 16 weeks
Secondary outcomes:
measure: monitor growth and development
timeFrame: 16 weeks
measure: monitor growth and development
timeFrame: 16 weeks
measure: monitor growth and development
timeFrame: 16 weeks
measure: assess dietary intake
timeFrame: 4 weeks, 8 weeks, 12 weeks, 16 weeks
measure: assess habitual pattern of food and beverage intake
timeFrame: 16 weeks
measure: assess child developmental milestones
timeFrame: 16 weeks
measure: assess fortified milk acceptability
timeFrame: 4 weeks, 8 weeks, 12 weeks, 16 weeks
measure: nucleotides status assessment
timeFrame: 16 weeks
measure: monitor standard adverse events (AE)
timeFrame: 16 weeks
measure: monitor absenteeism from day care or pre-school due to illness
timeFrame: 16 weeks
measure: monitor concomitant medication (CM) reporting
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Las Piñas
country: Philippines
facility: Las Piñas Doctors Hospital
state: Metro Manila
Study officials:
affiliation: Las Piñas Doctors Hospital
name: Elvira M Estorninos, MD
role: PRINCIPAL_INVESTIGATOR
References: