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

July 19, 2023 updated by: Société des Produits Nestlé (SPN)
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Philippines
    • Metro Manila
      • Las Piñas, Metro Manila, Philippines
        • Las Piñas Doctors Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 4 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent.
  2. 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
  3. Age 3 years old to 4 years old and 6 months at enrolment
  4. 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
  5. 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
  6. 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
  7. Child's parent(s)/guardian can be contacted directly by telephone or mobile phone throughout the study

Exclusion Criteria:

  1. Chronic infectious, metabolic, genetic illness, or other disease including any condition that impacts feeding, or any outcome measures
  2. Child exhibits any clinical signs of potential micronutrient deficiencies (e.g., hemoglobin < 100 g/L based on screening assessment, rickets based on physical exam).
  3. Known or suspected cows' milk protein intolerance / lactose intolerance /allergy or severe food allergies that impact diet
  4. Breast milk used exclusively / mixed in place of all other milk, and/or milk alternatives at 3 years of age
  5. Consuming supplement(s) of relevance to the study outcome relating diet to status, vitamins A, D, E and C; zinc
  6. Child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fortified milk group
2 daily servings of the investigational fortified milk for 16 weeks
Other: Fortified milk
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
No Intervention: Observational group
will be asked to consume beverages in accordance with their habitual pattern of intake

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in vitamin A status
Time Frame: 16 weeks
measure in serum retinol in μmol/L
16 weeks
change in vitamin C status
Time Frame: 16 weeks
measure in plasma vitamin C in mg/dL
16 weeks
change in vitamin D status
Time Frame: 16 weeks
measure in serum 25-hydroxy vitamin D (25[OH]D) in nmol/L
16 weeks
change in vitamin E status
Time Frame: 16 weeks
measure in plasma alpha-tocopherol in mg/L
16 weeks
change in zinc status
Time Frame: 16 weeks
measure in plasma zinc in μg/dl
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
monitor growth and development
Time Frame: 16 weeks
anthropometry assessment measured by weight (kg)
16 weeks
monitor growth and development
Time Frame: 16 weeks
anthropometry assessment measured by height (cm)
16 weeks
monitor growth and development
Time Frame: 16 weeks
anthropometry assessment measured by BMI (kg/m^2)
16 weeks
assess dietary intake
Time Frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks
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
Time Frame: 16 weeks
using a semi-quantitative food frequency questionnaire completed by the parent / caregiver
16 weeks
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
16 weeks
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
4 weeks, 8 weeks, 12 weeks, 16 weeks
nucleotides status assessment
Time Frame: 16 weeks
measure concentration of nucleotides
16 weeks
monitor standard adverse events (AE)
Time Frame: 16 weeks
safety assessment by monitoring the AEs linked with participation in study
16 weeks
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
16 weeks
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
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société des Produits Nestlé (SPN)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elvira M Estorninos, MD, Las Piñas Doctors Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020.01.INF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings