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

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).

Study Overview

• Status: Completed
• Conditions: Nutritional Status; Child Nutrition Sciences; Toddlers
• Intervention / Treatment: Other: Fortified milk

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Metro Manila
    • Las Piñas, Metro Manila, Philippines
      • Las Pinas Doctors Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 4 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fortified milk group; 2 daily servings of the investigational fortified milk for 16 weeks	Other: 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
No Intervention: Observational group; will be asked to consume beverages in accordance with their habitual pattern of intake

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Elvira M Estorninos, MD, Las Pinas Doctors Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Actual): December 14, 2022
• Study Completion (Actual): December 14, 2022

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2020.01.INF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No