<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/NCT02994212</url>
  </required_header>
  <id_info>
    <org_study_id>821414-1</org_study_id>
    <nct_id>NCT02994212</nct_id>
  </id_info>
  <brief_title>Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety</brief_title>
  <official_title>Reduced Frequency of Visits in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Epicentre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Médecins Sans Frontières, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Epicentre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Community-based management of severe acute malnutrition (SAM) has been shown to be safe and&#xD;
      cost-effective, but program coverage remains low. New treatment models that maintain high&#xD;
      levels of clinical effectiveness but allow for increased coverage are still needed. A reduced&#xD;
      schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on&#xD;
      a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to&#xD;
      describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic&#xD;
      food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and&#xD;
      household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot&#xD;
      intervention study in which 115 children eligible for the outpatient treatment of SAM were&#xD;
      provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis&#xD;
      for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm&#xD;
      circumference) MUAC gain, weight loss &gt; 5%, and the development of edema. Unannounced&#xD;
      household spot checks were conducted over 4 weeks to assess household utilization of RUTF and&#xD;
      storage practices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>weight gain</measure>
    <time_frame>4 weeks</time_frame>
    <description>grams/kilograms/day gained</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mid-upper arm circumference gain (mm/day)</measure>
    <time_frame>4 weeks</time_frame>
    <description>millimeters gained per day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weight loss &gt; 5%</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>development of edema</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>correct utilization of RUTF</measure>
    <time_frame>4 weeks</time_frame>
    <description>&gt; 2 sachets deviance between available and expected RUTF stocks at unannounced household visits</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">115</enrollment>
  <condition>Severe Acute Malnutrition</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Monthly distribution of RUTF</intervention_name>
    <description>115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a) being eligible for new admission to treatment of uncomplicated SAM&#xD;
&#xD;
          -  b) being resident within 15 km of the study health center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previously default from previous SAM treatment (e.g. missed 2 consecutive weekly&#xD;
             visits)&#xD;
&#xD;
          -  considered a relapse case (e.g. re-admitted within three months of previous discharge)&#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>Sheila Isanaka, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Epicentre</affiliation>
  </overall_official>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 3, 2019</last_update_submitted>
  <last_update_submitted_qc>December 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 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>Severe Acute 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/NCT02994212
org study id: 821414-1
nct id: NCT02994212
lead sponsor: 
collaborator: 
has dmc: No
Community-based management of severe acute malnutrition (SAM) has been shown to be safe and
      cost-effective, but program coverage remains low. New treatment models that maintain high
      levels of clinical effectiveness but allow for increased coverage are still needed. A reduced
      schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on
      a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to
      describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic
      food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and
      household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot
      intervention study in which 115 children eligible for the outpatient treatment of SAM were
      provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis
      for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm
      circumference) MUAC gain, weight loss > 5%, and the development of edema. Unannounced
      household spot checks were conducted over 4 weeks to assess household utilization of RUTF and
      storage practices.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: weight gain
time frame: 4 weeks
description: grams/kilograms/day gained
measure: mid-upper arm circumference gain (mm/day)
time frame: 4 weeks
description: millimeters gained per day
measure: weight loss > 5%
time frame: 4 weeks
measure: development of edema
time frame: 4 weeks
measure: correct utilization of RUTF
time frame: 4 weeks
description: > 2 sachets deviance between available and expected RUTF stocks at unannounced household visits
arm group label: Intervention group
arm group type: Experimental
description: 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response.
intervention type: Dietary Supplement
intervention name: Monthly distribution of RUTF
description: 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 6 Months
maximum age: 59 Months
healthy volunteers: No
last name: Sheila Isanaka, ScD
role: Principal Investigator
affiliation: Epicentre
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Severe Acute Malnutrition
sharing ipd: No