<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/NCT02201225</url>
  </required_header>
  <id_info>
    <org_study_id>201133</org_study_id>
    <secondary_id>RH01817</secondary_id>
    <nct_id>NCT02201225</nct_id>
  </id_info>
  <brief_title>A Methodology Study to Evaluate a Sitting Knee Measuring Device in Assessing Growth in Indian Children.</brief_title>
  <official_title>A Methodology Study to Evaluate a Sitting Knee Measuring Device in Assessing Growth in Indian Children Aged 6 to 12 Years Receiving Nutritional Supplement With or Without Micronutrient Fortification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This methodology study will evaluate the sensitivity in using sitting knee digital caliper to&#xD;
      measure changes in sitting knee length from over a 12-week study period amidst children in&#xD;
      the age of 6 to 12 years in a community-based study in children ages 6 to 12 years who are&#xD;
      receiving nutritional supplementation with micronutrients or without micronutrients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">March 13, 2015</completion_date>
  <primary_completion_date type="Actual">March 1, 2015</primary_completion_date>
  <phase>Phase 1</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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline to Week 12 in bone growth, as measured by sitting knee length caliper.</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>To evaluate the sensitivity of a sitting knee digital caliper to measure changes in sitting knee length from Baseline to Week 12 in a community-based study in the presence of nutritional supplementation with or without micronutrients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 12 in Z-score based on the standing height</measure>
    <time_frame>Baseline-Week 12</time_frame>
    <description>Comparison of standing height and sitting knee height to asses growth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 8 in bone growth, as measured by sitting knee length digital caliper</measure>
    <time_frame>Baseline-Week 8</time_frame>
    <description>To assess the relationship between changes from Baseline to Week 8 in sitting knee length and standing height in the presence of nutritional supplementation with or without micronutrients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Nutritional Status</condition>
  <arm_group>
    <arm_group_label>Nutritional supplement with micronutrient</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutritional supplement without micronutrient</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutritional supplement with micronutrient</intervention_name>
    <description>Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve</description>
    <arm_group_label>Nutritional supplement with micronutrient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutritional supplement without micronutrient</intervention_name>
    <description>Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve</description>
    <arm_group_label>Nutritional supplement without micronutrient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children (participants), both boys and girls, aged 6 to 12 years.&#xD;
&#xD;
          -  Participant height to be within the 25th to the 75th percentile of the standard height&#xD;
             average in Indian children population&#xD;
&#xD;
          -  Participant will agree not to take any other nutritional supplements products during&#xD;
             the study except the trial supplement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has any of the following medical conditions: Genetic disorders, chronic&#xD;
             disease, metabolic disorders, endocrine disorders, immobilisation, and miscellaneous&#xD;
&#xD;
          -  Participant who in the past 6 months has used dietary or nutritional supplements with&#xD;
             micronutrient fortification, or any form of dietary or herbal supplement intended to&#xD;
             increase micronutrient intake, at a frequency of greater than 3-4times per month.&#xD;
&#xD;
          -  Participant receiving any supplements (such as calcium, iron and/or multivitamin at&#xD;
             the time of screening).&#xD;
&#xD;
          -  Children (Participant) in Care are not allowed to participate in the study.&#xD;
&#xD;
          -  Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study&#xD;
             materials (or closely related compounds) or any of their stated ingredients.&#xD;
&#xD;
          -  Health conditions that would affect food metabolism including the following food&#xD;
             allergies, kidney disease, liver disease, and/or gastrointestinal diseases (e.g.&#xD;
             irritable bowel syndrome, celiac disease, peptic ulcers).&#xD;
&#xD;
          -  Use of concomitant medications that, in the opinion of the Principal Investigator&#xD;
             (PI), might interfere with the outcome of the study or increases the risk of the&#xD;
             participant, including corticosteroids (systemic or inhaled) and any medication for&#xD;
             any behaviour-related disorders and/or stimulants.&#xD;
&#xD;
          -  Current or relevant history of any serious, severe or unstable physical or psychiatric&#xD;
             illness or any medical disorder, including history of alcohol or substance abuse, that&#xD;
             would make the participant unlikely to fully complete the study or any condition that&#xD;
             presents undue risk from the study product or procedures in the opinion of the&#xD;
             PI/medical examiner.&#xD;
&#xD;
          -  Clinical Study/Experimental Medication: Participation in another clinical study or&#xD;
             receipt of an investigational drug within 30 days of the screening visit.&#xD;
&#xD;
          -  Personnel: Currently, the participant's parents/legal guardian is an employee of the&#xD;
             Sponsor or the study or members of their immediate family.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bangalore</city>
        <zip>560043</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>January 10, 2018</last_update_submitted>
  <last_update_submitted_qc>January 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Micronutrients</mesh_term>
    <mesh_term>Trace Elements</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02201225
org study id: 201133
secondary id: RH01817
nct id: NCT02201225
lead sponsor: 
has dmc: No
This methodology study will evaluate the sensitivity in using sitting knee digital caliper to
      measure changes in sitting knee length from over a 12-week study period amidst children in
      the age of 6 to 12 years in a community-based study in children ages 6 to 12 years who are
      receiving nutritional supplementation with micronutrients or without micronutrients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from Baseline to Week 12 in bone growth, as measured by sitting knee length caliper.
time frame: Baseline to Week 12
description: To evaluate the sensitivity of a sitting knee digital caliper to measure changes in sitting knee length from Baseline to Week 12 in a community-based study in the presence of nutritional supplementation with or without micronutrients.
measure: Change from Baseline to Week 12 in Z-score based on the standing height
time frame: Baseline-Week 12
description: Comparison of standing height and sitting knee height to asses growth
measure: Change from Baseline to Week 8 in bone growth, as measured by sitting knee length digital caliper
time frame: Baseline-Week 8
description: To assess the relationship between changes from Baseline to Week 8 in sitting knee length and standing height in the presence of nutritional supplementation with or without micronutrients
arm group label: Nutritional supplement with micronutrient
arm group type: Active Comparator
description: Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily
arm group label: Nutritional supplement without micronutrient
arm group type: Sham Comparator
description: Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily
intervention type: Dietary Supplement
intervention name: Nutritional supplement with micronutrient
description: Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve
arm group label: Nutritional supplement with micronutrient
intervention type: Dietary Supplement
intervention name: Nutritional supplement without micronutrient
description: Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve
arm group label: Nutritional supplement without micronutrient
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: India
responsible party type: Sponsor
mesh term: Micronutrients
mesh term: Trace Elements