<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/NCT02253095</url>
  </required_header>
  <id_info>
    <org_study_id>EE-zinc-alb-micronut</org_study_id>
    <nct_id>NCT02253095</nct_id>
  </id_info>
  <brief_title>Combined Package of Interventions for Environmental Enteropathy</brief_title>
  <official_title>Randomized, Double Blind, Placebo Controlled Trial Comparing the Impact of a Combined Package of Interventions vs Placebo in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Malawi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, double-blind, placebo controlled trial of a combined intervention of zinc,&#xD;
      albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian&#xD;
      children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dual Sugar Absorption Test</measure>
    <time_frame>12 weeks</time_frame>
    <description>lactulose-mannitol ratio in urine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dual Sugar Absorption Test</measure>
    <time_frame>24 weeks</time_frame>
    <description>lactulose-mannitol ratio in urine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lactulose Excretion</measure>
    <time_frame>12 weeks</time_frame>
    <description>percentage of ingested lactulose excreted in urine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lactulose Excretion</measure>
    <time_frame>24 weeks</time_frame>
    <description>percentage of ingested lactulose excreted in urine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mannitol Excretion</measure>
    <time_frame>12 weeks</time_frame>
    <description>percentage of ingested mannitol excreted in urine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mannitol Excretion</measure>
    <time_frame>24 weeks</time_frame>
    <description>percentage of ingested mannitol excreted in urine</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">253</enrollment>
  <condition>Environmental Enteropathy</condition>
  <arm_group>
    <arm_group_label>Multiple Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>three placebos</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albendazole</intervention_name>
    <arm_group_label>Multiple Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Zinc</intervention_name>
    <arm_group_label>Multiple Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Multiple Micronutrient Supplement</intervention_name>
    <arm_group_label>Multiple Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children residing in catchment area of Limela, Machinga District, Malawi&#xD;
&#xD;
          -  aged 12-35 months&#xD;
&#xD;
          -  youngest eligible child in each household&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe acute malnutrition&#xD;
&#xD;
          -  severe chronic illness&#xD;
&#xD;
          -  children unable to drink 20 mL of dual sugar solution&#xD;
&#xD;
          -  children in need of acute medical treatment for illness or injury at time of&#xD;
             enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>35 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark J Manary, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University in St. Louis; University of Malawi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chrissie Thakwalakwa, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Malawi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Indi Trehan, MD MPH DTM&amp;H</last_name>
    <role>Study Director</role>
    <affiliation>Washington University in St. Louis; University of Malawi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Limela Rural Site</name>
      <address>
        <city>Limela</city>
        <state>Machinga Distric</state>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>June 2, 2015</last_update_submitted>
  <last_update_submitted_qc>June 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Micronutrients</mesh_term>
    <mesh_term>Trace Elements</mesh_term>
    <mesh_term>Albendazole</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/NCT02253095
org study id: EE-zinc-alb-micronut
nct id: NCT02253095
lead sponsor: 
collaborator: 
has dmc: No
Randomized, double-blind, placebo controlled trial of a combined intervention of zinc,
      albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian
      children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Dual Sugar Absorption Test
time frame: 12 weeks
description: lactulose-mannitol ratio in urine
measure: Dual Sugar Absorption Test
time frame: 24 weeks
description: lactulose-mannitol ratio in urine
measure: Lactulose Excretion
time frame: 12 weeks
description: percentage of ingested lactulose excreted in urine
measure: Lactulose Excretion
time frame: 24 weeks
description: percentage of ingested lactulose excreted in urine
measure: Mannitol Excretion
time frame: 12 weeks
description: percentage of ingested mannitol excreted in urine
measure: Mannitol Excretion
time frame: 24 weeks
description: percentage of ingested mannitol excreted in urine
arm group label: Multiple Intervention Arm
arm group type: Experimental
description: single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients
arm group label: Placebo
arm group type: Placebo Comparator
description: three placebos
intervention type: Drug
intervention name: Albendazole
arm group label: Multiple Intervention Arm
intervention type: Dietary Supplement
intervention name: Zinc
arm group label: Multiple Intervention Arm
intervention type: Dietary Supplement
intervention name: Multiple Micronutrient Supplement
arm group label: Multiple Intervention Arm
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Months
maximum age: 35 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Mark J Manary, MD
role: Principal Investigator
affiliation: Washington University in St. Louis; University of Malawi
last name: Chrissie Thakwalakwa, PhD
role: Study Director
affiliation: University of Malawi
last name: Indi Trehan, MD MPH DTM&H
role: Study Director
affiliation: Washington University in St. Louis; University of Malawi
facility: 
country: Malawi
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Micronutrients
mesh term: Trace Elements
mesh term: Albendazole