Status:
COMPLETED
Nutrient and Immunity Status in Children Aged 3-5 Years Consuming Their Habitual Diet With or Without Fortified Milk
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Nutritional Status
Child Nutrition Sciences
Eligibility:
All Genders
36-54 years
Phase:
NA
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 be...
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 bever...
Eligibility Criteria
Inclusion
- Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent.
- 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
- Age 3 years old to 4 years old and 6 months at enrolment
- 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
- 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
- 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
- Child's parent(s)/guardian can be contacted directly by telephone or mobile phone throughout the study
Exclusion
- Chronic infectious, metabolic, genetic illness, or other disease including any condition that impacts feeding, or any outcome measures
- Child exhibits any clinical signs of potential micronutrient deficiencies (e.g., hemoglobin \< 100 g/L based on screening assessment, rickets based on physical exam).
- Known or suspected cows' milk protein intolerance / lactose intolerance /allergy or severe food allergies that impact diet
- Breast milk used exclusively / mixed in place of all other milk, and/or milk alternatives at 3 years of age
- Consuming supplement(s) of relevance to the study outcome relating diet to status, vitamins A, D, E and C; zinc
- Child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05440604
Start Date
June 23 2022
End Date
December 14 2022
Last Update
July 20 2023
Active Locations (1)
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1
Las Piñas Doctors Hospital
Las Piñas, National Capital Region, Philippines