Micronutrient Status in Children Aged 1-3 Years Consuming Their Habitual Diet With or Without Young Children's Milk

July 28, 2022 updated by: Nestlé
This study evaluates changes in Vitamin D, Zinc, and Iron status of children consuming 2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks compared to children of the same age who consume their habitual pattern of beverage intake for the same duration.

Study Overview

Status

Status

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

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

The overall purpose of the study is to demonstrate improved vitamin D status and/or improved iron status of children ages 1 to 3 years who are consuming the investigational (test) young children's milk (YCM) compared to children consuming their habitual pattern of beverage intake (milk and non-milk beverages). This is based on previous study findings that (i) the toddler's diet, in reality, is often not optimal, putting toddlers at risk of insufficient intakes of several nutrients, and (ii) consuming YCM 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.
29

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 Locations

  • Indonesia
    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 10430
        • Indonesian Nutrition Association

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

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent has been obtained from the parent.
  • Full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
  • Child is age 12 - 32 months at enrolment.
  • Child is no longer being breastfed (neither exclusively nor partially)
  • Child's parent is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria:

  • Child has consumed micronutrient supplements or micronutrient fortified foods or beverages in amounts greater than the thresholds below:

    1. Micronutrient supplements (except for vitamin A): zero in the past 4 weeks
    2. Micronutrient-fortified foods or beverages: zero servings in the past 2 weeks
  • Chronic infectious illness, helminthiasis, or other acute disease/disorder potentially affecting feeding or growth (mild infectious illness, such as acute viral rhinopharyngitis, is acceptable).
  • Any congenital malformation (e.g., gastrointestinal tract atresia) or surgery sequelae (e.g. short bowel syndrome) potentially affecting feeding, growth, or nutrient absorption.
  • 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 / allergy, lactose intolerance, soy intolerance / allergy, fish oil intolerance / allergy, or other food allergies that affect diet.
  • Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded.
  • Weight-for-age value < -2 or > 2 standard deviations from the WHO(world health organization) Child Growth Standards median at enrollment.
  • Height-for-age < -2 or > 2 standard deviations from the WHO(world health organization) Child Growth Standards median at enrollment.
  • Child has participated in another clinical trial within 4 weeks prior to enrollment.
  • Child of any investigational site staff member or Nestle employee directly involved in the conduct of the trial.
  • Other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study.

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: YCM Group (1- <3) Years old
2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks
Other: Young children's milk (1-<3)
young children's milk containing protein, energy and fat and micronutrients, in accordance with global and local nutritional recommendations for ages 1-3.
Other Names:
  • YCM
No Intervention: Observation Group (1-<3) Years old
Habitual diet, consume the same regular foods and drinks as the children would normally

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 D and Iron status
Time Frame: 16 weeks
measure blood vitamin D and Iron value
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
change in Zinc status
Time Frame: 16 weeks
measure blood Zinc value
16 weeks
Assess micronutrient intake
Time Frame: 16 weeks
Using 24 hour dietary recall
16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
assess other nutrient biomarkers
Time Frame: 16 weeks
measure changes by blood measurement for CRP in mg/L
16 weeks
assess other nutrient biomarkers
Time Frame: 16 weeks
measure changes by blood measurement for serum retinol in μmol/L
16 weeks
assess other nutrient biomarkers
Time Frame: 16 weeks
measure changes by blood measurement for alpha(1)-acid glycoprotein in absolute value
16 weeks
assess muscular fitness
Time Frame: 16 weeks
measure changes by blood measurement for serum niacin
16 weeks
assess muscular fitness
Time Frame: 16 weeks
measure changes by blood measurement for plasma vitamin B6
16 weeks
assess child developmental milestones
Time Frame: 16 weeks
measure Ages & Stages Questionnaires, Third Edition; Minimum 0, Maximum 60, higher scores indicate more positive outcomes
16 weeks
assess child developmental milestones
Time Frame: 16 weeks
measure Ages & Stages Questionnaires: Social-Emotional, Second Edition, Minimum 0, Maximum 180, lower scores indicate more positive outcomes
16 weeks
assess bone mass index
Time Frame: 16 weeks
measure the development of bone mass
16 weeks
assess muscular fitness
Time Frame: 16 weeks
measure handgrip strength using a portable dynamometer
16 weeks
assess stool microbiota composition and metabolism and gut biomarkers
Time Frame: 16 weeks
measure stool microbiota composition and metabolism, plus biomarkers of gut function (e.g., calprotectin, alpha-1 antitrypsin, albumin) and short-chain fatty acids.
16 weeks
assess genetic markers of vitamin D metabolism / status
Time Frame: baseline
measure genetic variants isolated from blood draw
baseline
assess gastrointestinal (GI) tolerance
Time Frame: 16 weeks
measure changes in gut comfort level min 10, max 60. Lower score indicate more positive outcomes
16 weeks
assess YCM acceptability in children consuming GUM.
Time Frame: 16 weeks
measure how well acceptable is YCM for interventional group, minimum score 5 max score 33. higher score indicate positive outcome
16 weeks
To monitor growth and development
Time Frame: 16 weeks
Anthropometry Assessment based on BMI in (kg/m^2) by weight (Kilograms), height (Metres)
16 weeks
To monitor standard adverse events (AE)
Time Frame: 16 weeks
safety assessment by monitoring the AEs linked with participation in study
16 weeks
To 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
To monitor concomitant medication (CM) reporting
Time Frame: 16 weeks
safety assessment by monitoring the 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.
Nestlé

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: Sudigdo Sastroasmoro, MD, Department of Child Health, Medical School, University of Indonesia

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.
October 22, 2021

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.
May 24, 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.
July 20, 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).
April 27, 2020

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.
May 28, 2020

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.
June 4, 2020

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.
August 1, 2022

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 28, 2022

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, 2022

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.
  • 19.08.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.

Clinical Trials on Nutritional Status

Clinical Trials on Young children's milk (1-<3)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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