<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/NCT01724073</url>
  </required_header>
  <id_info>
    <org_study_id>IRD-UMR204-NA1</org_study_id>
    <secondary_id>IRSAT-DTA Burkina Faso</secondary_id>
    <nct_id>NCT01724073</nct_id>
  </id_info>
  <brief_title>Regular Consumption of Leafy Vegetable Sauces and Micro-nutrient Status of Young Children in Burkina Faso</brief_title>
  <acronym>Instapa-WP4</acronym>
  <official_title>Effect of the Regular Consumption of Leafy-vegetable Sauces, Rich in Iron, Zinc and Vitamin A, on Growth and Micro-nutrient Status of Young Children in Burkina Faso</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Recherche pour le Developpement</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>IRSAT DTA Burkina Faso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hopital Yalgado Ouedraogo Burkina Faso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut de Recherche pour le Developpement</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A food-to-food fortification strategy has been designed based on traditional foods of Burkina&#xD;
      Faso to fight against micronutrient deficiencies in young children. Leafy vegetable sauces&#xD;
      were formulated to improve their micronutrient contents and bioavailability. This efficacy&#xD;
      study was designed to assess the effects of the regular consumption (one meal per day, 6 days&#xD;
      per week) of these leafy-vegetable sauces enriched or not with liver on iron, zinc and&#xD;
      vitamin A status, growth and morbidity of young children from poor urban districts of&#xD;
      Ouagadougou. The study is conducted by IRD and IRSAT-DTA and will last 6 months. 432 12-15&#xD;
      month-old children will be recruited and randomly assigned to one of the four following arms:&#xD;
      three intervention groups, the two first receiving leafy vegetable sauce, the third one&#xD;
      receiving one meal made of the fortified Misola gruel. In these three arms, blood samples&#xD;
      will be collected at the beginning and at the end of the study. The fourth arm is an external&#xD;
      control group and will not receive any food. In this fourth arm, blood samples will be&#xD;
      collected only at the end of the study. Biochemical indicators of micronutrient status will&#xD;
      be determined, and anthropometric data will be collected in all children. Morbidity will also&#xD;
      be assessed in children of intervention groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Micronutrient deficiencies and stunting are a major health concern in young children of many&#xD;
      developing countries, including Burkina Faso. This poor nutritional status affects health,&#xD;
      with a much higher risk for mortality, and delayed physical and cognitive development.&#xD;
&#xD;
      The INSTAPA project focuses on the improvement of millet-, sorghum-, maize-, and&#xD;
      cassava-based foods for young children in sub-Saharan Africa to safely prevent deficiencies&#xD;
      of iron, zinc, and vitamin A.&#xD;
&#xD;
      Food-to-food fortification strategy has rarely been tested in efficacy studies, despite its&#xD;
      promising sustainability. The study will be conducted by IRD, IRSAT-DTA, with funding of the&#xD;
      European Union.&#xD;
&#xD;
      Subjects of the study, 12-15 month old burkinabè children will be divided into 4 arms. 108&#xD;
      children per group (432, in all) will be recruited in order to have 90 children in each group&#xD;
      after exclusion due severe anemia or hemoglobinopathy. Each enrolled child will be dewormed&#xD;
      according to WHO recommendations, and receive a bed-net for malaria prevention.&#xD;
&#xD;
      Three of these four groups will receive one test meal per day, 6 days per week (except&#xD;
      Sunday)in canteens located in study districts. Investigators will record every day the amount&#xD;
      of food consumed and morbidity in each child.&#xD;
&#xD;
        -  one intervention group receiving leafy vegetable-fish sauce + cereal-based paste called&#xD;
           tô,&#xD;
&#xD;
        -  one intervention group receiving leafy vegetable-fish sauce + cereal-based paste called&#xD;
           tô 5 days/week and leafy vegetable-fish sauce + tô 1 day/week,&#xD;
&#xD;
        -  one 'positive control' group receiving a fortified gruel prepared from Misola Flour In&#xD;
           these three arms, blood samples will be collected at the beginning and at the end of the&#xD;
           study.&#xD;
&#xD;
      The fourth arm is an external control group and will not receive any food. In this fourth&#xD;
      arm, blood samples will be collected only at the end of the study.&#xD;
&#xD;
      Biochemical indicators of iron, zinc and vitamin A status will be determined, and&#xD;
      anthropometric data will be collected in all children.&#xD;
&#xD;
      The study is submitted to the Ethical committee of the Ministry of Health of Burkina Faso and&#xD;
      to the review board of the local drug administration (DGPML) for approval, as well as to the&#xD;
      Ethical committee of IRD (France).&#xD;
&#xD;
      According to the results, recommendations on the young child diet will be formulated for the&#xD;
      attention of the staff of health facilities and families.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Approval denied by national ethical committee of Burkina Faso&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <primary_completion_date type="Anticipated">May 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in micronutrient status</measure>
    <time_frame>six months</time_frame>
    <description>iron, zinc and vitamin A status using plasma concentrations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Growth</measure>
    <time_frame>6 months</time_frame>
    <description>Weight, length, mid-upper arm circumference</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>food consumption</measure>
    <time_frame>at t=around 1 month</time_frame>
    <description>weighed record during one whole day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intake of experimental food</measure>
    <time_frame>up to 6 months</time_frame>
    <description>the amount of experimental food eaten by each child will be weighed every day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>up to 6 months</time_frame>
    <description>daily record by questionnaire</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Leafy vegetable-fish sauce</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one meal per day, 6 days a week, with leafy vegetable-fish sauce + tô, a local cereal-based paste</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Leafy vegetable-fish/liver sauce</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one meal per day, 6 days a week, 5 days with leafy vegetable-fish sauce + tô, 1 day with leafy vegetable-liver sauce + tô</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Misola</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one meal per day, 6 days a week, with gruel prepared with the fortified Misola flour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no test food</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group receiving no test food</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Leafy vegetable-fish sauce</intervention_name>
    <arm_group_label>Leafy vegetable-fish sauce</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Leafy vegetable-fish/liver sauce</intervention_name>
    <arm_group_label>Leafy vegetable-fish/liver sauce</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Misola</intervention_name>
    <arm_group_label>Misola</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 12 and 15 months&#xD;
&#xD;
          -  signed informed consent by parent or caregiver&#xD;
&#xD;
          -  accept to eat every ingredient used for the preparation of the sauces&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any chronic illness affecting growth or iron status (thalassemia or sickle-cell&#xD;
             anemia) no informed consent&#xD;
&#xD;
          -  severe acute malnutrition which will require direct treatment&#xD;
&#xD;
          -  severe anemia which will require direct treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>15 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire Mouquet-Rivier, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Recherche pour le Developpement</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bréhima Diawara, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Recherche en Sciences Aplliquées et Technologie - DTA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut de Recherche en Sciences Aplliquées et Technologie - DTA</name>
      <address>
        <city>Ouagadougou</city>
        <state>Centre</state>
        <country>Burkina Faso</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
  </location_countries>
  <link>
    <url>http://www.nutripass.ird.fr/</url>
    <description>website of the research unit of the principal investigator</description>
  </link>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>March 4, 2014</last_update_submitted>
  <last_update_submitted_qc>March 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut de Recherche pour le Developpement</investigator_affiliation>
    <investigator_full_name>Claire Mouquet-Rivier</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>food to food fortification strategy</keyword>
  <keyword>leafy vegetable</keyword>
  <keyword>iron</keyword>
  <keyword>zinc</keyword>
  <keyword>vitamin A</keyword>
  <keyword>growth</keyword>
  <!-- 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/NCT01724073
org study id: IRD-UMR204-NA1
secondary id: IRSAT-DTA Burkina Faso
nct id: NCT01724073
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
A food-to-food fortification strategy has been designed based on traditional foods of Burkina
      Faso to fight against micronutrient deficiencies in young children. Leafy vegetable sauces
      were formulated to improve their micronutrient contents and bioavailability. This efficacy
      study was designed to assess the effects of the regular consumption (one meal per day, 6 days
      per week) of these leafy-vegetable sauces enriched or not with liver on iron, zinc and
      vitamin A status, growth and morbidity of young children from poor urban districts of
      Ouagadougou. The study is conducted by IRD and IRSAT-DTA and will last 6 months. 432 12-15
      month-old children will be recruited and randomly assigned to one of the four following arms:
      three intervention groups, the two first receiving leafy vegetable sauce, the third one
      receiving one meal made of the fortified Misola gruel. In these three arms, blood samples
      will be collected at the beginning and at the end of the study. The fourth arm is an external
      control group and will not receive any food. In this fourth arm, blood samples will be
      collected only at the end of the study. Biochemical indicators of micronutrient status will
      be determined, and anthropometric data will be collected in all children. Morbidity will also
      be assessed in children of intervention groups.
Micronutrient deficiencies and stunting are a major health concern in young children of many
      developing countries, including Burkina Faso. This poor nutritional status affects health,
      with a much higher risk for mortality, and delayed physical and cognitive development.

      The INSTAPA project focuses on the improvement of millet-, sorghum-, maize-, and
      cassava-based foods for young children in sub-Saharan Africa to safely prevent deficiencies
      of iron, zinc, and vitamin A.

      Food-to-food fortification strategy has rarely been tested in efficacy studies, despite its
      promising sustainability. The study will be conducted by IRD, IRSAT-DTA, with funding of the
      European Union.

      Subjects of the study, 12-15 month old burkinabè children will be divided into 4 arms. 108
      children per group (432, in all) will be recruited in order to have 90 children in each group
      after exclusion due severe anemia or hemoglobinopathy. Each enrolled child will be dewormed
      according to WHO recommendations, and receive a bed-net for malaria prevention.

      Three of these four groups will receive one test meal per day, 6 days per week (except
      Sunday)in canteens located in study districts. Investigators will record every day the amount
      of food consumed and morbidity in each child.

        -  one intervention group receiving leafy vegetable-fish sauce + cereal-based paste called
           tô,

        -  one intervention group receiving leafy vegetable-fish sauce + cereal-based paste called
           tô 5 days/week and leafy vegetable-fish sauce + tô 1 day/week,

        -  one 'positive control' group receiving a fortified gruel prepared from Misola Flour In
           these three arms, blood samples will be collected at the beginning and at the end of the
           study.

      The fourth arm is an external control group and will not receive any food. In this fourth
      arm, blood samples will be collected only at the end of the study.

      Biochemical indicators of iron, zinc and vitamin A status will be determined, and
      anthropometric data will be collected in all children.

      The study is submitted to the Ethical committee of the Ministry of Health of Burkina Faso and
      to the review board of the local drug administration (DGPML) for approval, as well as to the
      Ethical committee of IRD (France).

      According to the results, recommendations on the young child diet will be formulated for the
      attention of the staff of health facilities and families.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in micronutrient status
time frame: six months
description: iron, zinc and vitamin A status using plasma concentrations
measure: Growth
time frame: 6 months
description: Weight, length, mid-upper arm circumference
measure: food consumption
time frame: at t=around 1 month
description: weighed record during one whole day
measure: Intake of experimental food
time frame: up to 6 months
description: the amount of experimental food eaten by each child will be weighed every day
measure: Morbidity
time frame: up to 6 months
description: daily record by questionnaire
arm group label: Leafy vegetable-fish sauce
arm group type: Experimental
description: one meal per day, 6 days a week, with leafy vegetable-fish sauce + tô, a local cereal-based paste
arm group label: Leafy vegetable-fish/liver sauce
arm group type: Experimental
description: one meal per day, 6 days a week, 5 days with leafy vegetable-fish sauce + tô, 1 day with leafy vegetable-liver sauce + tô
arm group label: Misola
arm group type: Experimental
description: one meal per day, 6 days a week, with gruel prepared with the fortified Misola flour
arm group label: no test food
arm group type: No Intervention
description: control group receiving no test food
intervention type: Dietary Supplement
intervention name: Leafy vegetable-fish sauce
arm group label: Leafy vegetable-fish sauce
intervention type: Dietary Supplement
intervention name: Leafy vegetable-fish/liver sauce
arm group label: Leafy vegetable-fish/liver sauce
intervention type: Dietary Supplement
intervention name: Misola
arm group label: Misola
criteria: 
gender: All
minimum age: 12 Months
maximum age: 15 Months
healthy volunteers: No
last name: Claire Mouquet-Rivier, PhD
role: Principal Investigator
affiliation: Institut de Recherche pour le Developpement
last name: Bréhima Diawara, PhD
role: Principal Investigator
affiliation: Institut de Recherche en Sciences Aplliquées et Technologie - DTA
facility: 
country: Burkina Faso
url: http://www.nutripass.ird.fr/
description: website of the research unit of the principal investigator
responsible party type: Principal Investigator
investigator affiliation: Institut de Recherche pour le Developpement
investigator full name: Claire Mouquet-Rivier
investigator title: PhD