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

N

Nestlé

Status

Completed

Conditions

Nutritional Status
Child Nutrition Sciences
Toddlers

Treatments

Other: Fortified milk

Study type

Interventional

Funder types

Industry

Identifiers

NCT05440604
2020.01.INF

Details and patient eligibility

About

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).

Full 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.

Enrollment

112 patients

Sex

All

Ages

36 to 54 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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