<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04413604</url>
  </required_header>
  <id_info>
    <org_study_id>19.08.INF</org_study_id>
    <nct_id>NCT04413604</nct_id>
  </id_info>
  <brief_title>Micronutrient Status in Children Aged 1-3 Years Consuming Their Habitual Diet With or Without Young Children's Milk</brief_title>
  <official_title>Micronutrient Status in Children Aged 1-3 Years Consuming Their Habitual Diet With or Without Young Children's Milk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates changes in Vitamin D, Zinc, and Iron status of children consuming 2&#xD;
      servings / day of the investigational (test) young children's milk (YCM) for 16 weeks&#xD;
      compared to children of the same age who consume their habitual pattern of beverage intake&#xD;
      for the same duration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall purpose of the study is to demonstrate improved vitamin D status and/or improved&#xD;
      iron status of children ages 1 to 3 years who are consuming the investigational (test) young&#xD;
      children's milk (YCM) compared to children consuming their habitual pattern of beverage&#xD;
      intake (milk and non-milk beverages). This is based on previous study findings that (i) the&#xD;
      toddler's diet, in reality, is often not optimal, putting toddlers at risk of insufficient&#xD;
      intakes of several nutrients, and (ii) consuming YCM supplemented with these nutrients might&#xD;
      provide optimal intakes of these nutrients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to recruitment difficulties&#xD;
  </why_stopped>
  <start_date type="Actual">October 22, 2021</start_date>
  <completion_date type="Actual">July 20, 2022</completion_date>
  <primary_completion_date type="Actual">May 24, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in Vitamin D and Iron status</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure blood vitamin D and Iron value</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in Zinc status</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure blood Zinc value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess micronutrient intake</measure>
    <time_frame>16 weeks</time_frame>
    <description>Using 24 hour dietary recall</description>
  </secondary_outcome>
  <other_outcome>
    <measure>assess other nutrient biomarkers</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure changes by blood measurement for CRP in mg/L</description>
  </other_outcome>
  <other_outcome>
    <measure>assess other nutrient biomarkers</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure changes by blood measurement for serum retinol in μmol/L</description>
  </other_outcome>
  <other_outcome>
    <measure>assess other nutrient biomarkers</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure changes by blood measurement for alpha(1)-acid glycoprotein in absolute value</description>
  </other_outcome>
  <other_outcome>
    <measure>assess muscular fitness</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure changes by blood measurement for serum niacin</description>
  </other_outcome>
  <other_outcome>
    <measure>assess muscular fitness</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure changes by blood measurement for plasma vitamin B6</description>
  </other_outcome>
  <other_outcome>
    <measure>assess child developmental milestones</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure Ages &amp; Stages Questionnaires, Third Edition; Minimum 0, Maximum 60, higher scores indicate more positive outcomes</description>
  </other_outcome>
  <other_outcome>
    <measure>assess child developmental milestones</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure Ages &amp; Stages Questionnaires: Social-Emotional, Second Edition, Minimum 0, Maximum 180, lower scores indicate more positive outcomes</description>
  </other_outcome>
  <other_outcome>
    <measure>assess bone mass index</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure the development of bone mass</description>
  </other_outcome>
  <other_outcome>
    <measure>assess muscular fitness</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure handgrip strength using a portable dynamometer</description>
  </other_outcome>
  <other_outcome>
    <measure>assess stool microbiota composition and metabolism and gut biomarkers</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure stool microbiota composition and metabolism, plus biomarkers of gut function (e.g., calprotectin, alpha-1 antitrypsin, albumin) and short-chain fatty acids.</description>
  </other_outcome>
  <other_outcome>
    <measure>assess genetic markers of vitamin D metabolism / status</measure>
    <time_frame>baseline</time_frame>
    <description>measure genetic variants isolated from blood draw</description>
  </other_outcome>
  <other_outcome>
    <measure>assess gastrointestinal (GI) tolerance</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure changes in gut comfort level min 10, max 60. Lower score indicate more positive outcomes</description>
  </other_outcome>
  <other_outcome>
    <measure>assess YCM acceptability in children consuming GUM.</measure>
    <time_frame>16 weeks</time_frame>
    <description>measure how well acceptable is YCM for interventional group, minimum score 5 max score 33. higher score indicate positive outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>To monitor growth and development</measure>
    <time_frame>16 weeks</time_frame>
    <description>Anthropometry Assessment based on BMI in (kg/m^2) by weight (Kilograms), height (Metres)</description>
  </other_outcome>
  <other_outcome>
    <measure>To monitor standard adverse events (AE)</measure>
    <time_frame>16 weeks</time_frame>
    <description>safety assessment by monitoring the AEs linked with participation in study</description>
  </other_outcome>
  <other_outcome>
    <measure>To monitor absenteeism from day care or pre-school due to illness</measure>
    <time_frame>16 weeks</time_frame>
    <description>safety assessment by monitoring the days of absenteeism linked with participation in study</description>
  </other_outcome>
  <other_outcome>
    <measure>To monitor concomitant medication (CM) reporting</measure>
    <time_frame>16 weeks</time_frame>
    <description>safety assessment by monitoring the concomitant medication linked with participation in study</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Nutritional Status</condition>
  <condition>Child Nutrition Sciences</condition>
  <arm_group>
    <arm_group_label>YCM Group (1- &lt;3) Years old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation Group (1-&lt;3) Years old</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Habitual diet, consume the same regular foods and drinks as the children would normally</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Young children's milk (1-&lt;3)</intervention_name>
    <description>young children's milk containing protein, energy and fat and micronutrients, in accordance with global and local nutritional recommendations for ages 1-3.</description>
    <arm_group_label>YCM Group (1- &lt;3) Years old</arm_group_label>
    <other_name>YCM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent has been obtained from the parent.&#xD;
&#xD;
          -  Full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight&#xD;
             of ≥ 2.5 kg and ≤ 4.5 kg.&#xD;
&#xD;
          -  Child is age 12 - 32 months at enrolment.&#xD;
&#xD;
          -  Child is no longer being breastfed (neither exclusively nor partially)&#xD;
&#xD;
          -  Child's parent is of legal age of consent, must understand the informed consent form&#xD;
             and other study documents, and is willing and able to fulfill the requirements of the&#xD;
             study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child has consumed micronutrient supplements or micronutrient fortified foods or&#xD;
             beverages in amounts greater than the thresholds below:&#xD;
&#xD;
               1. Micronutrient supplements (except for vitamin A): zero in the past 4 weeks&#xD;
&#xD;
               2. Micronutrient-fortified foods or beverages: zero servings in the past 2 weeks&#xD;
&#xD;
          -  Chronic infectious illness, helminthiasis, or other acute disease/disorder potentially&#xD;
             affecting feeding or growth (mild infectious illness, such as acute viral&#xD;
             rhinopharyngitis, is acceptable).&#xD;
&#xD;
          -  Any congenital malformation (e.g., gastrointestinal tract atresia) or surgery sequelae&#xD;
             (e.g. short bowel syndrome) potentially affecting feeding, growth, or nutrient&#xD;
             absorption.&#xD;
&#xD;
          -  Child exhibits any clinical signs of potential micronutrient deficiencies (e.g.,&#xD;
             hemoglobin &lt; 100 g/L based on screening assessment, rickets based on physical exam).&#xD;
&#xD;
          -  Known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy&#xD;
             intolerance / allergy, fish oil intolerance / allergy, or other food allergies that&#xD;
             affect diet.&#xD;
&#xD;
          -  Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are&#xD;
             excluded.&#xD;
&#xD;
          -  Weight-for-age value &lt; -2 or &gt; 2 standard deviations from the WHO(world health&#xD;
             organization) Child Growth Standards median at enrollment.&#xD;
&#xD;
          -  Height-for-age &lt; -2 or &gt; 2 standard deviations from the WHO(world health organization)&#xD;
             Child Growth Standards median at enrollment.&#xD;
&#xD;
          -  Child has participated in another clinical trial within 4 weeks prior to enrollment.&#xD;
&#xD;
          -  Child of any investigational site staff member or Nestle employee directly involved in&#xD;
             the conduct of the trial.&#xD;
&#xD;
          -  Other medical or psychiatric condition that, in the judgement of the investigator,&#xD;
             would make the child inappropriate for entry into the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>32 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sudigdo Sastroasmoro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Child Health, Medical School, University of Indonesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indonesian Nutrition Association</name>
      <address>
        <city>Jakarta Pusat</city>
        <state>Jakarta</state>
        <zip>10430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>April 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 28, 2022</last_update_submitted>
  <last_update_submitted_qc>July 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04413604
org study id: 19.08.INF
nct id: NCT04413604
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: change in Vitamin D and Iron status
time frame: 16 weeks
description: measure blood vitamin D and Iron value
measure: change in Zinc status
time frame: 16 weeks
description: measure blood Zinc value
measure: Assess micronutrient intake
time frame: 16 weeks
description: Using 24 hour dietary recall
measure: assess other nutrient biomarkers
time frame: 16 weeks
description: measure changes by blood measurement for CRP in mg/L
measure: assess other nutrient biomarkers
time frame: 16 weeks
description: measure changes by blood measurement for serum retinol in μmol/L
measure: assess other nutrient biomarkers
time frame: 16 weeks
description: measure changes by blood measurement for alpha(1)-acid glycoprotein in absolute value
measure: assess muscular fitness
time frame: 16 weeks
description: measure changes by blood measurement for serum niacin
measure: assess muscular fitness
time frame: 16 weeks
description: measure changes by blood measurement for plasma vitamin B6
measure: assess child developmental milestones
time frame: 16 weeks
description: measure Ages & Stages Questionnaires, Third Edition; Minimum 0, Maximum 60, higher scores indicate more positive outcomes
measure: assess child developmental milestones
time frame: 16 weeks
description: measure Ages & Stages Questionnaires: Social-Emotional, Second Edition, Minimum 0, Maximum 180, lower scores indicate more positive outcomes
measure: assess bone mass index
time frame: 16 weeks
description: measure the development of bone mass
measure: assess muscular fitness
time frame: 16 weeks
description: measure handgrip strength using a portable dynamometer
measure: assess stool microbiota composition and metabolism and gut biomarkers
time frame: 16 weeks
description: measure stool microbiota composition and metabolism, plus biomarkers of gut function (e.g., calprotectin, alpha-1 antitrypsin, albumin) and short-chain fatty acids.
measure: assess genetic markers of vitamin D metabolism / status
time frame: baseline
description: measure genetic variants isolated from blood draw
measure: assess gastrointestinal (GI) tolerance
time frame: 16 weeks
description: measure changes in gut comfort level min 10, max 60. Lower score indicate more positive outcomes
measure: assess YCM acceptability in children consuming GUM.
time frame: 16 weeks
description: measure how well acceptable is YCM for interventional group, minimum score 5 max score 33. higher score indicate positive outcome
measure: To monitor growth and development
time frame: 16 weeks
description: Anthropometry Assessment based on BMI in (kg/m^2) by weight (Kilograms), height (Metres)
measure: To monitor standard adverse events (AE)
time frame: 16 weeks
description: safety assessment by monitoring the AEs linked with participation in study
measure: To monitor absenteeism from day care or pre-school due to illness
time frame: 16 weeks
description: safety assessment by monitoring the days of absenteeism linked with participation in study
measure: To monitor concomitant medication (CM) reporting
time frame: 16 weeks
description: safety assessment by monitoring the concomitant medication linked with participation in study
arm group label: YCM Group (1- <3) Years old
arm group type: Experimental
description: 2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks
arm group label: Observation Group (1-<3) Years old
arm group type: No Intervention
description: Habitual diet, consume the same regular foods and drinks as the children would normally
intervention type: Other
intervention name: Young children's milk (1-<3)
description: young children's milk containing protein, energy and fat and micronutrients, in accordance with global and local nutritional recommendations for ages 1-3.
arm group label: YCM Group (1- <3) Years old
other name: YCM
criteria: 
gender: All
minimum age: 12 Months
maximum age: 32 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Sudigdo Sastroasmoro, MD
role: Principal Investigator
affiliation: Department of Child Health, Medical School, University of Indonesia
facility: 
country: Indonesia
responsible party type: Sponsor