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

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

Sponsors

Lead Sponsor: Nestlé

Source Nestlé
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.

Overall Status Recruiting
Start Date 2022-06-23
Completion Date 2023-02-28
Primary Completion Date 2022-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
change in vitamin A status 16 weeks
change in vitamin C status 16 weeks
change in vitamin D status 16 weeks
change in vitamin E status 16 weeks
change in zinc status 16 weeks
Secondary Outcome
Measure Time Frame
monitor growth and development 16 weeks
monitor growth and development 16 weeks
monitor growth and development 16 weeks
assess dietary intake 4 weeks, 8 weeks, 12 weeks, 16 weeks
assess habitual pattern of food and beverage intake 16 weeks
assess child developmental milestones 16 weeks
assess fortified milk acceptability 4 weeks, 8 weeks, 12 weeks, 16 weeks
nucleotides status assessment 16 weeks
monitor standard adverse events (AE) 16 weeks
monitor absenteeism from day care or pre-school due to illness 16 weeks
monitor concomitant medication (CM) reporting 16 weeks
Enrollment 112
Condition
Intervention

Intervention Type: Other

Intervention Name: Fortified milk

Description: 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

Arm Group Label: Fortified milk group

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

Gender:

All

Minimum Age:

36 Months

Maximum Age:

54 Months

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Elvira M Estorninos, MD Principal Investigator Las Piñas Doctors Hospital
Overall Contact

Last Name: Jowena D Lebumfacil, PhD

Phone: +6328846646

Email: [email protected]

Location
Facility: Status: Contact: Las Piñas Doctors Hospital Elvira M Estorninos, MD +639178259302 [email protected]
Location Countries

Philippines

Verification Date

2022-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Fortified milk group

Type: Experimental

Description: 2 daily servings of the investigational fortified milk for 16 weeks

Label: Observational group

Type: No Intervention

Description: will be asked to consume beverages in accordance with their habitual pattern of intake

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: None (Open Label)

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