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).
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
112
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
Las Piñas Doctors Hospital
Las Piñas, National Capital Region, Philippines
change in vitamin A status
measure in serum retinol in μmol/L
Time frame: 16 weeks
change in vitamin C status
measure in plasma vitamin C in mg/dL
Time frame: 16 weeks
change in vitamin D status
measure in serum 25-hydroxy vitamin D (25\[OH\]D) in nmol/L
Time frame: 16 weeks
change in vitamin E status
measure in plasma alpha-tocopherol in mg/L
Time frame: 16 weeks
change in zinc status
measure in plasma zinc in μg/dl
Time frame: 16 weeks
monitor growth and development
anthropometry assessment measured by weight (kg)
Time frame: 16 weeks
monitor growth and development
anthropometry assessment measured by height (cm)
Time frame: 16 weeks
monitor growth and development
anthropometry assessment measured by BMI (kg/m\^2)
Time frame: 16 weeks
assess dietary intake
using a 24-hour Dietary Recall completed by the parent / caregiver
Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks
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assess habitual pattern of food and beverage intake
using a semi-quantitative food frequency questionnaire completed by the parent / caregiver
Time frame: 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
Time frame: 16 weeks
assess fortified milk acceptability
using Milk Intake Diary for interventional group completed by the parent / caregiver
Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks
nucleotides status assessment
measure concentration of nucleotides
Time frame: 16 weeks
monitor standard adverse events (AE)
safety assessment by monitoring the AEs linked with participation in study
Time frame: 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
Time frame: 16 weeks
monitor concomitant medication (CM) reporting
safety assessment by monitoring number of participants that took concomitant medication linked with participation in study
Time frame: 16 weeks