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

Nutritional Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05440604
• Other study ID #: 2020.01.INF
• Status: Completed
• Phase: N/A
• Start date: June 23, 2022
• Est. completion date: December 14, 2022

Study information

• Verified date: July 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Months to 54 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Sciences
• Nutritional Status
• Toddlers

Intervention

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

Locations

Country	Name	City	State
Philippines	Las Piñas Doctors Hospital	Las Piñas	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in vitamin A status	measure in serum retinol in µmol/L	16 weeks
Primary	change in vitamin C status	measure in plasma vitamin C in mg/dL	16 weeks
Primary	change in vitamin D status	measure in serum 25-hydroxy vitamin D (25[OH]D) in nmol/L	16 weeks
Primary	change in vitamin E status	measure in plasma alpha-tocopherol in mg/L	16 weeks
Primary	change in zinc status	measure in plasma zinc in µg/dl	16 weeks
Secondary	monitor growth and development	anthropometry assessment measured by weight (kg)	16 weeks
Secondary	monitor growth and development	anthropometry assessment measured by height (cm)	16 weeks
Secondary	monitor growth and development	anthropometry assessment measured by BMI (kg/m^2)	16 weeks
Secondary	assess dietary intake	using a 24-hour Dietary Recall completed by the parent / caregiver	4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary	assess habitual pattern of food and beverage intake	using a semi-quantitative food frequency questionnaire completed by the parent / caregiver	16 weeks
Secondary	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
Secondary	assess fortified milk acceptability	using Milk Intake Diary for interventional group completed by the parent / caregiver	4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary	nucleotides status assessment	measure concentration of nucleotides	16 weeks
Secondary	monitor standard adverse events (AE)	safety assessment by monitoring the AEs linked with participation in study	16 weeks
Secondary	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
Secondary	monitor concomitant medication (CM) reporting	safety assessment by monitoring number of participants that took concomitant medication linked with participation in study	16 weeks