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Nutritional StatusNCT05440604

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

A study testing Fortified milk in people with Nutritional Status and Child Nutrition Sciences, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 beverage intake (milk and non-milk beverages). Read more about this study

Who is it for?
Ages 36 to 54 monthsHealthy volunteers can take part
What is being tested?
Fortified milk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 sitePhilippines
Study dates
23 Jun 2022to 14 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 36 to 54 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Philippines1 site

  • Las Piñas Doctors Hospital

    Las Piñas, National Capital Region

Other trials in Philippines

About this study

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).

Read the 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 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.

Being tested
Fortified milk

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fortified milkOther

    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

Study groups in NCT05440604
Study groupRoleWhat they receive
Fortified milk groupExperimental2 daily servings of the investigational fortified milk for 16 weeks
Receives: Other: Fortified milk
Observational groupNo interventionwill be asked to consume beverages in accordance with their habitual pattern of intake

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in vitamin A status

    measure in serum retinol in μmol/L

    Measured: 16 weeks

  2. change in vitamin C status

    measure in plasma vitamin C in mg/dL

    Measured: 16 weeks

  3. change in vitamin D status

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

    Measured: 16 weeks

  4. change in vitamin E status

    measure in plasma alpha-tocopherol in mg/L

    Measured: 16 weeks

  5. change in zinc status

    measure in plasma zinc in μg/dl

    Measured: 16 weeks

Secondary outcomes (11)

  1. monitor growth and development

    anthropometry assessment measured by weight (kg)

    Measured: 16 weeks

  2. monitor growth and development

    anthropometry assessment measured by height (cm)

    Measured: 16 weeks

  3. monitor growth and development

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

    Measured: 16 weeks

  4. assess dietary intake

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

    Measured: 4 weeks, 8 weeks, 12 weeks, 16 weeks

  5. assess habitual pattern of food and beverage intake

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

    Measured: 16 weeks

  6. 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

    Measured: 16 weeks

  7. assess fortified milk acceptability

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

    Measured: 4 weeks, 8 weeks, 12 weeks, 16 weeks

  8. nucleotides status assessment

    measure concentration of nucleotides

    Measured: 16 weeks

  9. monitor standard adverse events (AE)

    safety assessment by monitoring the AEs linked with participation in study

    Measured: 16 weeks

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

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

    Measured: 16 weeks

  11. monitor concomitant medication (CM) reporting

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

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2022
  2. Study start23 Jun 2022
  3. Primary completion14 Dec 2022
  4. Study completion14 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05440604
Sponsor's protocol ID
2020.01.INF
Status last verified
Jul 2023
First submitted
27 Jun 2022
Last updated
20 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Fortified milk in people with Nutritional Status and Child Nutrition Sciences, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in vitamin A status (time frame: 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05440604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.

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