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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fortified milk group | Experimental | 2 daily servings of the investigational fortified milk for 16 weeks |
|
| Observational group | No Intervention | will be asked to consume beverages in accordance with their habitual pattern of intake |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortified milk | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elvira M Estorninos, MD | Las Piñas Doctors Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Las Piñas Doctors Hospital | Las Piñas | National Capital Region | Philippines |
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| 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 |