<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/NCT03017209</url>
  </required_header>
  <id_info>
    <org_study_id>12356</org_study_id>
    <nct_id>NCT03017209</nct_id>
  </id_info>
  <brief_title>Locally Prepared Supplement to Support Growth and Brain Health</brief_title>
  <official_title>Study on a Locally Prepared Food Supplement to Support Growth and Brain Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Global Food &amp; Nutrition Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tufts University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized controlled trial with a main goal to assess the effects of a&#xD;
      locally-prepared food for prevention of malnutrition and stunting, in comparison with&#xD;
      standard village practices and also a widely available aid food supplement in 8-12 villages&#xD;
      in Guinea-Bissau. The supplement intervention will be for 24-30 weeks. The primary outcome&#xD;
      will be cognitive tests of executive function. Secondary outcomes will be changes in standard&#xD;
      anthropometric benchmarks of growth, hemoglobin and skin carotenoids in young children living&#xD;
      in villages in rural Guinea-Bissau. This is a within-village randomization at the level of&#xD;
      the family, and all children will receive a dietary intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 1050 children aged 15 months to 6.99 years, and older children if in 1st grade&#xD;
      elementary school, in 8-12 villages in the Oio and Cachau regions of Guinea-Bissau will be&#xD;
      recruited for this study along with their maternal caregiver and father. Child ages will be&#xD;
      based on the official birth records which families possess. The mothers/primary caregivers&#xD;
      and fathers of the children will also be recruited for simple outcome assessments. Villages&#xD;
      will be a convenience sample chosen from villages within the network of our local research&#xD;
      partner International Partnership for Human Development. Each village in this region has one&#xD;
      school and one community health center per village, which will be involved in supplement&#xD;
      distribution and some outcome assessments.&#xD;
&#xD;
      Families with enrolling children will be randomized within 8-12 villages to receive 1 of 3&#xD;
      supplements and if any family (defined based on the father of the children since this is a&#xD;
      polygamous community) has more than one enrolling child all those children will be randomized&#xD;
      to the same supplement arm.&#xD;
&#xD;
        -  One supplement will be the locally-prepared bar&#xD;
&#xD;
        -  One will be an isocaloric amount of porridge prepared with USAIDs Corn Soy Blend Plus,&#xD;
           prepared as recommended in a 10:3 ratio with fortified vegetable oil.&#xD;
&#xD;
        -  One supplement will be an isocaloric amount of cooked rice with vegetable oil, which is&#xD;
           the typical local breakfast.&#xD;
&#xD;
      Villagers will be informed of the randomization after baseline testing is complete.&#xD;
&#xD;
      Following baseline measurements in children of anthropometry and body composition, grip&#xD;
      strength, cognition, hemoglobin, and skin carotenoids, children will receive their&#xD;
      intervention for 24-30 weeks and the same measurements taken at baseline will be repeated&#xD;
      during the last study week. The flexible end data is given to accommodate the local rainy&#xD;
      season and its impact on transportation. Please note that cell phone access to villages is&#xD;
      not influenced by local weather, thus communication regarding safety issues with community&#xD;
      health workers will remain possible throughout the entire trial.&#xD;
&#xD;
      Addendum: The pre-planned primary method of analysis was a per-protocol analysis, predefined&#xD;
      as children consuming ≥75% of their supplement. However, a clerical error in this clinical&#xD;
      trial registration did not describe this predetermined focus on a per-protocol population.&#xD;
      The registration implies an intention-to-treat (ITT) analysis by default. Investigators&#xD;
      therefore revised our analytical approach to designate the ITT cohort as the primary cohort&#xD;
      of interest. The secondary cohort of interest is the predefined per-protocol cohort (children&#xD;
      consuming ≥75% of their supplement).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cognitive function measured using executive functions tasks in children ages 15 months to 3 years</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in z-scores for weight (WAZ)</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in z-scores for height (HAZ)</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests for children &gt;3 years old</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
    <description>Looking to see changes in executive function who attend supplement distribution at least 75% of the days it is offered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mid-upper arm circumference</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral blood flow</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
    <description>By infrared spectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Lean tissue and lean growth</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weight for height Z scores</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Carotenoids</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
    <description>By Resonance Raman Spectroscopy</description>
  </other_outcome>
  <other_outcome>
    <measure>Grip strength</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
    <description>Using a dynamometer</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight of female-caregivers and fathers</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Head circumference of child</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Height of female-caregivers and fathers</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mid upper arm circumference of female caregivers</measure>
    <time_frame>baseline and 24-30 weeks after baseline testing</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1059</enrollment>
  <condition>Malnutrition, Child</condition>
  <condition>Cognitive Function</condition>
  <arm_group>
    <arm_group_label>Locally-prepared bar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The bar is similar to one tested recently in a pilot study and is a locally prepared bar designed to facilitate growth and cognitive development. It will provide 300 kcal/day and will have ≈20-30% of energy from protein (of which 25-50% is from an animal protein source), 20-35% from total carbohydrate and ≈40-60% from fat. The bar will be fortified with vitamins and minerals to meet USAID recommendations for moderate malnutrition and Dietary Reference Intake recommendations for at-risk and healthy children of the ages studied, and at the same time will not exceed Upper Level nutrient recommendations for any micronutrient. Ingredients in the bar will be a combination of local products and imported shelf-stable ingredients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>USAID Corn Soy Blend Plus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The usual-intervention condition will be 300 kcal/day of USAID Corn Soy Blend Plus cooked in the usual manner with fortified vegetable oil (10:3 ratio) and sugar. The community health workers or other designated villagers will prepare the supplement freshly each intervention day using locally accepted standards for hygiene, and a quality control process for ratios of ingredients assigned by the research team to ensure consistent composition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Locally-purchased rice</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo condition will be 300 kcal/day of locally-purchased rice cooked with a small amount of oil (10:2 ratio), which mimics the usual breakfast of children in this region. The community health workers or other designated villagers will prepare the rice freshly each intervention day using locally accepted standards for hygiene, and a quality control process for ratios of ingredients assigned by the research team to ensure consistent composition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Locally-prepared bar</intervention_name>
    <description>School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.</description>
    <arm_group_label>Locally-prepared bar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>USAID Corn Soy Blend Plus</intervention_name>
    <description>School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.</description>
    <arm_group_label>USAID Corn Soy Blend Plus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.</description>
    <arm_group_label>Locally-purchased rice</arm_group_label>
    <other_name>Locally-purchased rice</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent or legal guardian provides consent for all children &lt;7 years and the parent&#xD;
             plus the child provide consent for any child &gt; 7 years.&#xD;
&#xD;
          -  Age 15 months to 6.99 years old or any age enrolled in first grade in the same&#xD;
             village.&#xD;
&#xD;
          -  The family plans to remain in the village for the duration of the study (up to 30&#xD;
             weeks) based on self-report by a parent;&#xD;
&#xD;
          -  The child does not have any known food allergies as reported by the mother or&#xD;
             guardian.&#xD;
&#xD;
        Exclusion Criteria: If any child is identified as malnourished at baseline, defined as a&#xD;
        mid-upper arm circumference in the red zone of the paper tape, the child will be excluded&#xD;
        from the study due to malnutrition, and the parents will be advised to take the child to&#xD;
        the nearest malnutrition clinic.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Months</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan B Roberts, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Partnership for Health Development</name>
      <address>
        <city>Bissau</city>
        <zip>1000</zip>
        <country>Guinea-Bissau</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Guinea-Bissau</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 17, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>May 8, 2019</last_update_submitted>
  <last_update_submitted_qc>May 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2019</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>Malnutrition</mesh_term>
    <mesh_term>Child Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03017209
org study id: 12356
nct id: NCT03017209
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study is a randomized controlled trial with a main goal to assess the effects of a
      locally-prepared food for prevention of malnutrition and stunting, in comparison with
      standard village practices and also a widely available aid food supplement in 8-12 villages
      in Guinea-Bissau. The supplement intervention will be for 24-30 weeks. The primary outcome
      will be cognitive tests of executive function. Secondary outcomes will be changes in standard
      anthropometric benchmarks of growth, hemoglobin and skin carotenoids in young children living
      in villages in rural Guinea-Bissau. This is a within-village randomization at the level of
      the family, and all children will receive a dietary intervention.
Up to 1050 children aged 15 months to 6.99 years, and older children if in 1st grade
      elementary school, in 8-12 villages in the Oio and Cachau regions of Guinea-Bissau will be
      recruited for this study along with their maternal caregiver and father. Child ages will be
      based on the official birth records which families possess. The mothers/primary caregivers
      and fathers of the children will also be recruited for simple outcome assessments. Villages
      will be a convenience sample chosen from villages within the network of our local research
      partner International Partnership for Human Development. Each village in this region has one
      school and one community health center per village, which will be involved in supplement
      distribution and some outcome assessments.

      Families with enrolling children will be randomized within 8-12 villages to receive 1 of 3
      supplements and if any family (defined based on the father of the children since this is a
      polygamous community) has more than one enrolling child all those children will be randomized
      to the same supplement arm.

        -  One supplement will be the locally-prepared bar

        -  One will be an isocaloric amount of porridge prepared with USAIDs Corn Soy Blend Plus,
           prepared as recommended in a 10:3 ratio with fortified vegetable oil.

        -  One supplement will be an isocaloric amount of cooked rice with vegetable oil, which is
           the typical local breakfast.

      Villagers will be informed of the randomization after baseline testing is complete.

      Following baseline measurements in children of anthropometry and body composition, grip
      strength, cognition, hemoglobin, and skin carotenoids, children will receive their
      intervention for 24-30 weeks and the same measurements taken at baseline will be repeated
      during the last study week. The flexible end data is given to accommodate the local rainy
      season and its impact on transportation. Please note that cell phone access to villages is
      not influenced by local weather, thus communication regarding safety issues with community
      health workers will remain possible throughout the entire trial.

      Addendum: The pre-planned primary method of analysis was a per-protocol analysis, predefined
      as children consuming ≥75% of their supplement. However, a clerical error in this clinical
      trial registration did not describe this predetermined focus on a per-protocol population.
      The registration implies an intention-to-treat (ITT) analysis by default. Investigators
      therefore revised our analytical approach to designate the ITT cohort as the primary cohort
      of interest. The secondary cohort of interest is the predefined per-protocol cohort (children
      consuming ≥75% of their supplement).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in cognitive function measured using executive functions tasks in children ages 15 months to 3 years
time frame: baseline and 24-30 weeks after baseline testing
measure: Hemoglobin
time frame: baseline and 24-30 weeks after baseline testing
measure: Changes in z-scores for weight (WAZ)
time frame: baseline and 24-30 weeks after baseline testing
measure: Changes in z-scores for height (HAZ)
time frame: baseline and 24-30 weeks after baseline testing
measure: Cognitive tests for children >3 years old
time frame: baseline and 24-30 weeks after baseline testing
description: Looking to see changes in executive function who attend supplement distribution at least 75% of the days it is offered.
measure: Mid-upper arm circumference
time frame: baseline and 24-30 weeks after baseline testing
measure: Cerebral blood flow
time frame: baseline and 24-30 weeks after baseline testing
description: By infrared spectroscopy
measure: % Lean tissue and lean growth
time frame: baseline and 24-30 weeks after baseline testing
measure: Changes in weight for height Z scores
time frame: baseline and 24-30 weeks after baseline testing
measure: Carotenoids
time frame: baseline and 24-30 weeks after baseline testing
description: By Resonance Raman Spectroscopy
measure: Grip strength
time frame: baseline and 24-30 weeks after baseline testing
description: Using a dynamometer
measure: Weight of female-caregivers and fathers
time frame: baseline and 24-30 weeks after baseline testing
measure: Head circumference of child
time frame: baseline and 24-30 weeks after baseline testing
measure: Height of female-caregivers and fathers
time frame: baseline and 24-30 weeks after baseline testing
measure: Mid upper arm circumference of female caregivers
time frame: baseline and 24-30 weeks after baseline testing
arm group label: Locally-prepared bar
arm group type: Experimental
description: The bar is similar to one tested recently in a pilot study and is a locally prepared bar designed to facilitate growth and cognitive development. It will provide 300 kcal/day and will have ≈20-30% of energy from protein (of which 25-50% is from an animal protein source), 20-35% from total carbohydrate and ≈40-60% from fat. The bar will be fortified with vitamins and minerals to meet USAID recommendations for moderate malnutrition and Dietary Reference Intake recommendations for at-risk and healthy children of the ages studied, and at the same time will not exceed Upper Level nutrient recommendations for any micronutrient. Ingredients in the bar will be a combination of local products and imported shelf-stable ingredients.
arm group label: USAID Corn Soy Blend Plus
arm group type: Active Comparator
description: The usual-intervention condition will be 300 kcal/day of USAID Corn Soy Blend Plus cooked in the usual manner with fortified vegetable oil (10:3 ratio) and sugar. The community health workers or other designated villagers will prepare the supplement freshly each intervention day using locally accepted standards for hygiene, and a quality control process for ratios of ingredients assigned by the research team to ensure consistent composition.
arm group label: Locally-purchased rice
arm group type: Placebo Comparator
description: The placebo condition will be 300 kcal/day of locally-purchased rice cooked with a small amount of oil (10:2 ratio), which mimics the usual breakfast of children in this region. The community health workers or other designated villagers will prepare the rice freshly each intervention day using locally accepted standards for hygiene, and a quality control process for ratios of ingredients assigned by the research team to ensure consistent composition.
intervention type: Dietary Supplement
intervention name: Locally-prepared bar
description: School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
arm group label: Locally-prepared bar
intervention type: Dietary Supplement
intervention name: USAID Corn Soy Blend Plus
description: School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
arm group label: USAID Corn Soy Blend Plus
intervention type: Other
intervention name: Placebo
description: School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
arm group label: Locally-purchased rice
other name: Locally-purchased rice
criteria: 
gender: All
minimum age: 15 Months
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan B Roberts, PHD
role: Principal Investigator
affiliation: Tufts University
facility: 
country: Guinea-Bissau
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Child Nutrition Disorders
sharing ipd: No