<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/NCT03027505</url>
  </required_header>
  <id_info>
    <org_study_id>MUAC Only Burkina Faso</org_study_id>
    <nct_id>NCT03027505</nct_id>
  </id_info>
  <brief_title>Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso</brief_title>
  <acronym>MUAC-Only</acronym>
  <official_title>Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alliance for International Medical Action</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Association Keoogo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Recherche en Sciences de la Sante, Burkina Faso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SOS médecins Burkina Faso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Alliance for International Medical Action</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      MUAC only is a pilot trial external control carried out between January 2017 and December&#xD;
      2017 in the Yako district (northern region), Burkina Faso.&#xD;
&#xD;
      The objective of this study is to evaluate an integrated protocol for acute malnourished&#xD;
      children without medical complication. The hypotheses of the integrated protocol include :&#xD;
&#xD;
        1. A global treatment of acute malnutrition (moderate and severe) with a single treatment&#xD;
           (RUTF) would improve the functioning of the program through early identification of&#xD;
           acutely malnourished children, while achieving a better coverage and using a single&#xD;
           supply chain.&#xD;
&#xD;
        2. A gradual reduction of RUTF dosage according to a child's MUAC status could&#xD;
           significantly increase the number of children on treatment without increasing overall&#xD;
           RUTF quantity while maintaining similar recovery rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives :&#xD;
&#xD;
      Main objective :&#xD;
&#xD;
      To ensure the recovery rate of the integrated protocol for treatment of acute malnutrition is&#xD;
      significantly greater than 75% (reference value of the national program in BF).&#xD;
&#xD;
      Secondary objectives :&#xD;
&#xD;
        -  To ensure the mortality rate of the integrated protocol for treatment of acute&#xD;
           malnutrition is significantly lower than 3% (reference value of the national BF&#xD;
           program).&#xD;
&#xD;
        -  To ensure the default rate of the integrated protocol for treatment of acute&#xD;
           malnutrition is significantly lower than 15% (reference value of the national BF&#xD;
           program).&#xD;
&#xD;
        -  To ensure the non-response rate of the integrated protocol for treatment of acute&#xD;
           malnutrition is significantly lower than 8%.&#xD;
&#xD;
        -  To ensure the hospitalization rate of the integrated protocol for treatment of acute&#xD;
           malnutrition is significantly lower than 15%.&#xD;
&#xD;
        -  To ensure the coverage rate of the program increases by 30% after the year the&#xD;
           integrated protocol was introduced (specific protocol annexed).&#xD;
&#xD;
        -  To estimate the relapse rate of the integrated protocol for treatment of acute&#xD;
           malnutrition.&#xD;
&#xD;
        -  To compare RUTF rations per child of the integrated protocol compared to the national&#xD;
           protocol&#xD;
&#xD;
      Methods :&#xD;
&#xD;
      The study population will include all acutely malnourished children aged between 6 and 59&#xD;
      months seeking consultations at all of the health centers in Yako District between January&#xD;
      2017 and December 2017.&#xD;
&#xD;
      The study will be implemented in Burkina Faso's Yako District, which includes 54 health&#xD;
      centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recovery rate</measure>
    <time_frame>Between 4 and 12 weeks</time_frame>
    <description>The recovery is defined as below :&#xD;
Minimum of 4 weeks of participation in the program&#xD;
MUAC&gt; = 125 mm on 2 consecutive visits&#xD;
No edema for minimum 2 weeks&#xD;
Good Clinical Health</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>Between inclusion and week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Default rate</measure>
    <time_frame>Between 3 and 12 weeks</time_frame>
    <description>Patient absent for 3 consecutive visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-respondent rate</measure>
    <time_frame>12 weeks after inclusion</time_frame>
    <description>Patient who not reach the recovery criteria after twelve weeks in the program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization rate</measure>
    <time_frame>Between inclusion and week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse rate</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Patient having reached the recovery criteria and returning for a new episode of malnutrition (MUAC&lt;125mm).&#xD;
The children's MUAC will be measured at home 3 months after program exit. For organizational and financial reasons, this data will not be collected for all children. A specific protocol explaining the sampling and organization of data collection will be annexed to the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RUTF rations</measure>
    <time_frame>Between inclusion and week 12</time_frame>
    <description>Total number of RUTF bags received per child during participation in the program.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4958</enrollment>
  <condition>Global Acute Malnutrition (GAM)</condition>
  <arm_group>
    <arm_group_label>MUAC&lt;125mm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>no medical complication</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ready to Use Therapeutic Food (RUTF)</intervention_name>
    <description>MUAC used as the primary admission and exit criteria for children with MUAC &lt;125mm and no medical complication.&#xD;
Single treatment of RUTF for severe and moderate malnourished children and gradual reduction of doses according to the MUAC and the weight of the child during treatment. MUAC split into 3 categories:&#xD;
MUAC &lt;115 mm: 175 kcal /kg/day&#xD;
115 &lt;MUAC &lt;120mm: 125kcal/kg/day&#xD;
120 &lt;MUAC &lt;125mm: 75kcal/kg/day</description>
    <arm_group_label>MUAC&lt;125mm</arm_group_label>
    <other_name>MUAC&lt;125mm</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being between 6 and 59 months old&#xD;
&#xD;
          -  New admission&#xD;
&#xD;
          -  Acute malnutrition defined as follows:&#xD;
&#xD;
               -  MUAC&lt;125mm&#xD;
&#xD;
               -  MUAC&gt; 125mm AND WHZ (Z-score) &lt;-3 (WHO standard)&#xD;
&#xD;
               -  Edema&#xD;
&#xD;
          -  Resident in the study area (Yako district)&#xD;
&#xD;
          -  Signed informed consent of the mother or the child's guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children allergic to milk, peanuts and / or RUTF&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Shepherd, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Directrice de recherches Opérationnelles et Médicales, ALIMA, USA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Renaud Becquet, MPH,PhD,HDR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chercheur Inserm, Inserm U1219 Bordeaux Population Health Center-Université de Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ALIMA</name>
      <address>
        <city>Yako</city>
        <state>Region Nord</state>
        <country>Burkina Faso</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MUAC</keyword>
  <keyword>Acute malnutrition</keyword>
  <keyword>RUTF</keyword>
  <keyword>Children</keyword>
  <keyword>Burkina Faso</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</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/NCT03027505
org study id: MUAC Only Burkina Faso
nct id: NCT03027505
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
MUAC only is a pilot trial external control carried out between January 2017 and December
      2017 in the Yako district (northern region), Burkina Faso.

      The objective of this study is to evaluate an integrated protocol for acute malnourished
      children without medical complication. The hypotheses of the integrated protocol include :

        1. A global treatment of acute malnutrition (moderate and severe) with a single treatment
           (RUTF) would improve the functioning of the program through early identification of
           acutely malnourished children, while achieving a better coverage and using a single
           supply chain.

        2. A gradual reduction of RUTF dosage according to a child's MUAC status could
           significantly increase the number of children on treatment without increasing overall
           RUTF quantity while maintaining similar recovery rates.
Objectives :

      Main objective :

      To ensure the recovery rate of the integrated protocol for treatment of acute malnutrition is
      significantly greater than 75% (reference value of the national program in BF).

      Secondary objectives :

        -  To ensure the mortality rate of the integrated protocol for treatment of acute
           malnutrition is significantly lower than 3% (reference value of the national BF
           program).

        -  To ensure the default rate of the integrated protocol for treatment of acute
           malnutrition is significantly lower than 15% (reference value of the national BF
           program).

        -  To ensure the non-response rate of the integrated protocol for treatment of acute
           malnutrition is significantly lower than 8%.

        -  To ensure the hospitalization rate of the integrated protocol for treatment of acute
           malnutrition is significantly lower than 15%.

        -  To ensure the coverage rate of the program increases by 30% after the year the
           integrated protocol was introduced (specific protocol annexed).

        -  To estimate the relapse rate of the integrated protocol for treatment of acute
           malnutrition.

        -  To compare RUTF rations per child of the integrated protocol compared to the national
           protocol

      Methods :

      The study population will include all acutely malnourished children aged between 6 and 59
      months seeking consultations at all of the health centers in Yako District between January
      2017 and December 2017.

      The study will be implemented in Burkina Faso's Yako District, which includes 54 health
      centers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recovery rate
time frame: Between 4 and 12 weeks
description: The recovery is defined as below :
Minimum of 4 weeks of participation in the program
MUAC> = 125 mm on 2 consecutive visits
No edema for minimum 2 weeks
Good Clinical Health
measure: Mortality rate
time frame: Between inclusion and week 12
measure: Default rate
time frame: Between 3 and 12 weeks
description: Patient absent for 3 consecutive visits
measure: Non-respondent rate
time frame: 12 weeks after inclusion
description: Patient who not reach the recovery criteria after twelve weeks in the program
measure: Hospitalization rate
time frame: Between inclusion and week 12
measure: Relapse rate
time frame: up to 3 months
description: Patient having reached the recovery criteria and returning for a new episode of malnutrition (MUAC<125mm).
The children's MUAC will be measured at home 3 months after program exit. For organizational and financial reasons, this data will not be collected for all children. A specific protocol explaining the sampling and organization of data collection will be annexed to the protocol.
measure: RUTF rations
time frame: Between inclusion and week 12
description: Total number of RUTF bags received per child during participation in the program.
arm group label: MUAC<125mm
arm group type: Experimental
description: no medical complication
intervention type: Drug
intervention name: Ready to Use Therapeutic Food (RUTF)
description: MUAC used as the primary admission and exit criteria for children with MUAC <125mm and no medical complication.
Single treatment of RUTF for severe and moderate malnourished children and gradual reduction of doses according to the MUAC and the weight of the child during treatment. MUAC split into 3 categories:
MUAC <115 mm: 175 kcal /kg/day
115 <MUAC <120mm: 125kcal/kg/day
120 <MUAC <125mm: 75kcal/kg/day
arm group label: MUAC<125mm
other name: MUAC<125mm
criteria: 
gender: All
minimum age: 6 Months
maximum age: 59 Months
healthy volunteers: No
last name: Susan Shepherd, MD
role: Principal Investigator
affiliation: Directrice de recherches Opérationnelles et Médicales, ALIMA, USA
last name: Renaud Becquet, MPH,PhD,HDR
role: Principal Investigator
affiliation: Chercheur Inserm, Inserm U1219 Bordeaux Population Health Center-Université de Bordeaux
facility: 
country: Burkina Faso
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: No