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

NCT ID: NCT05440604

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-23
• Study Completion Date: 2022-12-14

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.

Conditions

Nutritional Status; Child Nutrition Sciences; Toddlers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fortified milk group

2 daily servings of the investigational fortified milk for 16 weeks

Group Type: EXPERIMENTAL

Fortified milk

Intervention Type: OTHER

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

Observational group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fortified milk

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 36 Months
• Maximum Eligible Age: 54 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elvira M Estorninos, MD

Role: PRINCIPAL_INVESTIGATOR

Las Piñas Doctors Hospital

Locations

Las Piñas Doctors Hospital

Las Piñas, National Capital Region, Philippines

Countries

Philippines

Other Identifiers

2020.01.INF

Identifier Type: -

Identifier Source: org_study_id