<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/NCT02254460</url>
  </required_header>
  <id_info>
    <org_study_id>202738</org_study_id>
    <secondary_id>RH01592</secondary_id>
    <nct_id>NCT02254460</nct_id>
  </id_info>
  <brief_title>Investigation of Iron Uptake From Micronutrient Fortified Powder Versus From Tailored Control in Milk</brief_title>
  <official_title>A Double Blind, Randomized, Two-way Cross-over Study to Investigate the Uptake of Iron From Micronutrient Fortified Powder vs. From Tailored Control in Milk.</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>
      The present study supplements iron as part of multiple micro-nutrient supplementation to&#xD;
      demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake&#xD;
      of key micronutrients like iron due to unique nature of the given matrix, as compared to&#xD;
      intake of iron alone in milk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 6, 2013</start_date>
  <completion_date type="Actual">March 8, 2013</completion_date>
  <primary_completion_date type="Actual">March 1, 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fractional Iron Absorption</measure>
    <time_frame>Day 15</time_frame>
    <description>Iron uptake was measured using stable isotopes of 57Fe and 58Fe to label the test and control products. Fractional iron absorption levels of 57Fe and 58Fe were calculated, to give a direct measure of the iron uptake from each of the study treatments.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Growth and Development</condition>
  <arm_group>
    <arm_group_label>Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Test</intervention_name>
    <description>Experimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve.</description>
    <arm_group_label>Test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Demonstrates understanding of the study and willingness to participate as evidenced by&#xD;
             participants' parents and/or legal guardian's voluntary written informed consent as&#xD;
             well as written assent by the participant and has received a signed and dated copy of&#xD;
             the informed consent form as well as the assent form&#xD;
&#xD;
          -  Participant belonging to middle socio-economic background as per modified Kuppuswamy&#xD;
             scale&#xD;
&#xD;
          -  Good general and mental health with, in the opinion of the investigator or medically&#xD;
             qualified designee&#xD;
&#xD;
          -  Child residing in the peri-urban areas of Bangalore city&#xD;
&#xD;
          -  Child with Z-scores of: a. height for age of 0 to ≥-3; b. BMI for age of 0 to ≥-3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children in Care (CiC)&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely&#xD;
             related compounds), any of their stated ingredients or any known food allergies like&#xD;
             peanut allergy, gluten allergy or lactose intolerance&#xD;
&#xD;
          -  Participants with severe anaemia (Haemoglobin &lt; 8g %) as determined by laboratory&#xD;
             results&#xD;
&#xD;
          -  Current or relevant history of any serious, severe or unstable physical or psychiatric&#xD;
             illness or any medical disorder that would make the participant unlikely to fully&#xD;
             complete the study or any condition that presents undue risk from the study product or&#xD;
             procedures in the opinion of the investigator&#xD;
&#xD;
          -  Recent history (3 months) of serious infections, injuries and/ or surgeries&#xD;
&#xD;
          -  Children consuming iron, calcium and/or other nutritional supplements and/ or health&#xD;
             food drinks on a regular basis (more than 3 times a week) in last 6 months prior to&#xD;
             screening visit&#xD;
&#xD;
          -  Use of any prescription medications within 15 days prior to screening and throughout&#xD;
             the entire duration of the study&#xD;
&#xD;
          -  Recent history (within the last 1 year) of alcohol or other substance abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>10 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>560034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <results_first_submitted>January 2, 2017</results_first_submitted>
  <results_first_submitted_qc>January 27, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 16, 2017</results_first_posted>
  <last_update_submitted>June 8, 2017</last_update_submitted>
  <last_update_submitted_qc>June 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from two centers in India.</recruitment_details>
      <pre_assignment_details>A total of 37 participants were screened, 25 were randomized and 24 completed the study. One participant withdrew from the study due to an adverse event (AE).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Test Followed by Control</title>
          <description>Patients first received micronutrient fortified nutritional beverage powder (test) and then energy, iron and calcium equivalent beverage powder without micronutrient fortification (control), packed as 27 grams (g) individual sachets, administered as a single serve in a total volume of 100 milliliters (mL) lukewarm milk for oral consumption. 1mL solution containing 3 milligrams/milliliters (mg/mL) of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage</description>
        </group>
        <group group_id="P2">
          <title>Control Follwed by Test</title>
          <description>Patients first received energy, iron and calcium equivalent beverage powder without micronutrient fortification (control) and then micronutrient fortified nutritional beverage powder (test), packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Overall</title>
          <description>Micronutrient fortified nutritional beverage powder (test) and energy, iron and calcium equivalent beverage powder without micronutrient fortification (control), packed as 27 g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.60" spread="1.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Fractional Iron Absorption</title>
        <description>Iron uptake was measured using stable isotopes of 57Fe and 58Fe to label the test and control products. Fractional iron absorption levels of 57Fe and 58Fe were calculated, to give a direct measure of the iron uptake from each of the study treatments.</description>
        <time_frame>Day 15</time_frame>
        <population>Per protocol (PP) population, defined as all participants who received at least one study treatment administration and who did not have any protocol violations deemed to affect evaluation of the iron absorption. This analysis was conducted on PP population.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Micronutrient fortified nutritional beverage powder, packed as 27g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (test). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Energy, iron and calcium equivalent beverage powder without micronutrient fortification, packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption.1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (control). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.</description>
          </group>
        </group_list>
        <measure>
          <title>Fractional Iron Absorption</title>
          <description>Iron uptake was measured using stable isotopes of 57Fe and 58Fe to label the test and control products. Fractional iron absorption levels of 57Fe and 58Fe were calculated, to give a direct measure of the iron uptake from each of the study treatments.</description>
          <population>Per protocol (PP) population, defined as all participants who received at least one study treatment administration and who did not have any protocol violations deemed to affect evaluation of the iron absorption. This analysis was conducted on PP population.</population>
          <units>% Iron Absorbed</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.08" spread="1.263"/>
                    <measurement group_id="O2" value="1.25" spread="0.922"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0944</p_value>
            <method>ANOVA</method>
            <param_type>[Treatment difference]</param_type>
            <param_value>1.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>3.34</ci_upper_limit>
            <estimate_desc>Treatment difference from ANOVA of log transformed data. Back transformed data are presented. This therefore represents the iron absorption ratio of the Micronutrient Fortified Drink (Test) to the Non-Fortified Drink (Control).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Test</title>
          <description>Micronutrient fortified nutritional beverage powder, packed as 27g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (test). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Energy, iron and calcium equivalent beverage powder without micronutrient fortification, packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe, 58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (control). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </point_of_contact>
  </clinical_results>
</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/NCT02254460
org study id: 202738
secondary id: RH01592
nct id: NCT02254460
lead sponsor: 
has dmc: No
The present study supplements iron as part of multiple micro-nutrient supplementation to
      demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake
      of key micronutrients like iron due to unique nature of the given matrix, as compared to
      intake of iron alone in milk.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fractional Iron Absorption
time frame: Day 15
description: Iron uptake was measured using stable isotopes of 57Fe and 58Fe to label the test and control products. Fractional iron absorption levels of 57Fe and 58Fe were calculated, to give a direct measure of the iron uptake from each of the study treatments.
arm group label: Test
arm group type: Experimental
description: Experimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve.
arm group label: Control
arm group type: Placebo Comparator
description: Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve
intervention type: Dietary Supplement
intervention name: Test
description: Experimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve.
arm group label: Test
intervention type: Other
intervention name: Control
description: Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve
arm group label: Control
criteria: 
gender: All
minimum age: 7 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: India
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 