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Completed

NCT Number: NCT05440604

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

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).

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Key information

Age range

36 month–54 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Las Piñas Doctors Hospital

Las Piñas, National Capital Region, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. change in vitamin A status

    Time frame: 16 weeks

    measure in serum retinol in μmol/L

  2. change in vitamin C status

    Time frame: 16 weeks

    measure in plasma vitamin C in mg/dL

  3. change in vitamin D status

    Time frame: 16 weeks

    measure in serum 25-hydroxy vitamin D (25[OH]D) in nmol/L

  4. change in vitamin E status

    Time frame: 16 weeks

    measure in plasma alpha-tocopherol in mg/L

  5. change in zinc status

    Time frame: 16 weeks

    measure in plasma zinc in μg/dl

Secondary outcomes

  1. monitor growth and development

    Time frame: 16 weeks

    anthropometry assessment measured by weight (kg)

  2. monitor growth and development

    Time frame: 16 weeks

    anthropometry assessment measured by height (cm)

  3. monitor growth and development

    Time frame: 16 weeks

    anthropometry assessment measured by BMI (kg/m^2)

  4. assess dietary intake

    Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks

    using a 24-hour Dietary Recall completed by the parent / caregiver

  5. assess habitual pattern of food and beverage intake

    Time frame: 16 weeks

    using a semi-quantitative food frequency questionnaire completed by the parent / caregiver

  6. assess child developmental milestones

    Time frame: 16 weeks

    using Laban Quotient to assess physical, social, self-help and cognitive; minimum score 1 , maximum 5; higher scores indicate more positive outcomes

  7. assess fortified milk acceptability

    Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks

    using Milk Intake Diary for interventional group completed by the parent / caregiver

  8. nucleotides status assessment

    Time frame: 16 weeks

    measure concentration of nucleotides

  9. monitor standard adverse events (AE)

    Time frame: 16 weeks

    safety assessment by monitoring the AEs linked with participation in study

  10. monitor absenteeism from day care or pre-school due to illness

    Time frame: 16 weeks

    safety assessment by monitoring the days of absenteeism linked with participation in study

  11. monitor concomitant medication (CM) reporting

    Time frame: 16 weeks

    safety assessment by monitoring number of participants that took concomitant medication linked with participation in study

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2022
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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