<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/NCT03751475</url>
  </required_header>
  <id_info>
    <org_study_id>OptiMA-DRC</org_study_id>
    <nct_id>NCT03751475</nct_id>
  </id_info>
  <brief_title>Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Democratic Republic of Congo</brief_title>
  <acronym>OptiMA-DRC</acronym>
  <official_title>Optimized and Simplified Management of Acute Malnutrition in Children Aged 6 to 59 Months: a Community-based Clinical Randomized Controlled Trial in the Democratic Republic of Congo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alliance for International Medical Action</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Public Health, Democratic Republic of the Congo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Innocent Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bordeaux, INSERM, Bordeaux Population Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Alliance for International Medical Action</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute malnutrition affects 51 million children under the age of 5 worldwide. Malnutrition&#xD;
      contributes to nearly half of all child deaths each year, with the forms characterized by&#xD;
      wasting or oedema (acute malnutrition) associated with the highest risk of death.&#xD;
&#xD;
      Although acute malnutrition is a continuum condition, it is arbitrarily divided into severe&#xD;
      and moderate acute malnutrition (SAM, MAM) which are managed separately, with programs&#xD;
      overseen by different UN agencies, and using different protocols and products. Such&#xD;
      separation complicates delivery of care, contributes to high default and low coverage, and&#xD;
      creates confusion among caregivers. Often treatment is only available for SAM children&#xD;
      resulting in lives lost and costly hospitalisation that could be averted if nutritional&#xD;
      support were available earlier in the wasting process. If we are to reduce the health and&#xD;
      mortality burden from malnutrition, the effectiveness and cost-effectiveness of current&#xD;
      protocols need dramatic improvements.&#xD;
&#xD;
      The dosage of Ready to Use Therapeutic Food (RUTF) for SAM (130-200 kcal/kg/d) has not&#xD;
      changed since introduction of out-patient protocols in the mid-2000s. Children classified as&#xD;
      SAM in these protocols are determined by three independent criteria: the presence of&#xD;
      nutritional oedema or MUAC &lt; 115 mm or weight-height Z score &lt;-3. The RUTF dosage in these&#xD;
      protocols is paradoxical in that the absolute amount of RUTF prescribed in the initial phases&#xD;
      of treatment is often less than that given as the child nears recovery, because the number of&#xD;
      packets in the weekly ration is determined by weight. However, rate of weight gain (g/kg/day)&#xD;
      is highest in the first two weeks of treatment, and then plateaus - suggesting no benefit of&#xD;
      increased RUTF amounts in the later phases of treatment. Progressive reduction seems to be a&#xD;
      more rational use of RUTF.&#xD;
&#xD;
      The Optimizing treatment for acute MAlnutrition (OptiMA) strategy consists in simplifying&#xD;
      management of acute malnutrition through the use of a single anthropometric admission&#xD;
      criterion (mid upper arm circumference [MUAC] &lt; 125 mm or nutritional oedema) - one that best&#xD;
      captures children's anthropometry related mortality risk- and by optimizing the use of RUTF&#xD;
      by adapting doses to the nutritional recovery of the child. RUTF doses begin at 170 kcal/kg/d&#xD;
      for the most severely wasted (MUAC &lt; 115 mm or oedema) and reduce to 75 kcal/kg/d as oedema&#xD;
      resolves and MUAC increases &gt; 120 mm.&#xD;
&#xD;
      The investigators hypothesize that this strategy could double the number of children in care&#xD;
      compared to current SAM programs without substantially increasing the amount of RUTF or&#xD;
      staffing required while maintaining a recovery rate in line with current programs. OptiMA may&#xD;
      also improve coverage and reduce the need for hospitalization through early identification of&#xD;
      malnourished children.&#xD;
&#xD;
      The investigators propose to conduct a community-based non-inferiority clinical trial with&#xD;
      individual randomization comparing the OptiMA strategy to the Democratic Republic of Congo&#xD;
      standard nutritional protocol for SAM. Study children will be randomly assigned to the&#xD;
      intervention arm or control arm - with children at MUAC &lt; 125 mm or oedema eligible for RUTF&#xD;
      in the intervention arm and those meeting current WHO SAM definition eligible in the control&#xD;
      group. All participants will be followed for 9 months post-randomization to assess&#xD;
      non-inferiority as defined by a composite of three endpoints : alive, acceptable nutritional&#xD;
      status (MUAC ≥ 125 mm and WHZ &gt;-3, no oedema) and no relapse to acute malnutrition for those&#xD;
      who were treated with RUTF. The main secondary outcome will assess the non-inferiority of&#xD;
      OptiMA RUTF dosing (170 kcal/kg/d) in children meeting current WHO SAM criteria compared to&#xD;
      children with the same criteria in the control arm who will receive 130-200 kcal/kg/d.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The OptiMA strategy proposes a new malnutrition management approach, grounded in 3 main&#xD;
      principles.&#xD;
&#xD;
      Firstly, the diagnosis of acute malnutrition is refined to target those at highest mortality&#xD;
      risk within the CMAM definition of acute malnutrition (WHZ &lt; -2 or MUAC &lt; 125 mm or oedema),&#xD;
      by targeting treatment to children with a MUAC &lt; 125 mm or oedema. The simplicity of MUAC&#xD;
      measure allows families to screen children and check for oedema at home and identify&#xD;
      malnourished children at an earlier stage. The diagnosis is quickly confirmed by clinicians&#xD;
      at the health center. MUAC progression is also used to monitor recovery and determine&#xD;
      discharge thus eliminating the discrepancies that occur when both MUAC and WHZ are used to&#xD;
      diagnose acute malnutrition.&#xD;
&#xD;
      Secondly, RUTF dosage is rationalized, and calibrated to the child's degree of wasting. The&#xD;
      WHZ tables and dosing tables are replaced by a single table that determines the child's RUTF&#xD;
      ration based on MUAC category and weight. Larger rations, on a per kilo basis, are given to&#xD;
      the most severely malnourished and the ration is reduced as the child progresses to recovery.&#xD;
&#xD;
      Thirdly, supply chain is simplified to a single RUTF and data management from 2 programs are&#xD;
      merged into one. This streamlined programme should result in better coverage, a high&#xD;
      proportion of children detected before MUAC&lt;115 mm, lower RUTF consumption per child and&#xD;
      fewer acute malnutrition related hospitalisations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2019</start_date>
  <completion_date type="Actual">July 20, 2020</completion_date>
  <primary_completion_date type="Actual">July 20, 2020</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>
    <intervention_model_description>2 parallel arms stratified on site and degree of acute malnutrition. 890 participants for the principal objective 480 participants with severe acute malnutrition for the secondary main objective</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate in each arm</measure>
    <time_frame>6 months after randomization</time_frame>
    <description>Success is defined by a composite indicator evaluated 6 months post-randomization:&#xD;
child alive and not acutely malnourished, per the same definition at inclusion : absence of oedema and MUAC ≥125mm and WHZ ≥-3 and&#xD;
for the duration of the 6-month observation period following randomization, the child does not develop another episode of acute malnutrition applying the same definition at study inclusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recovery rate in participants with severe acute malnutrition (WHO definition)</measure>
    <time_frame>After RUTF treatment, through the 6 month study completion</time_frame>
    <description>The recovery rate is defined by a MUAC≥125 (OptiMA arm) and a MUAC≥125 or a WHZ&gt;-1.5 (Standard Protocol arm) during two consecutive visits, absence of oedema, minimum treatment period of 4 weeks and good clinical condition</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Consumption of RUTF</measure>
    <time_frame>At the visit of recovery status occuring through the 6 month study completion</time_frame>
    <description>Comparaison of the median/mean of the total number of RUTF sachet administred between both arms in recovered SAM</description>
  </other_outcome>
  <other_outcome>
    <measure>Total weight gain and daily weight gain</measure>
    <time_frame>At the visit of recovery status occuring through the 6 month study completion</time_frame>
    <description>Comparaison of the median/mean of the total weight gain in grams and the daily weight gain in g/kg/d between both arms in recovered SAM children</description>
  </other_outcome>
  <other_outcome>
    <measure>Total MUAC gain and daily MUAC gain</measure>
    <time_frame>At the visit of recovery status occuring through the 6 month study completion</time_frame>
    <description>Comparaison of the median/mean of the total MUAC gain in mm and of the MUAC gain in mm/day in recovered SAM children between both arms</description>
  </other_outcome>
  <other_outcome>
    <measure>Total length of RUTF treatment</measure>
    <time_frame>At the visit of recovery status occuring through the 6 month study completion</time_frame>
    <description>Comparaison of the median/mean of the total number of days with RUTF treatment in recovered SAM children between both arms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Absence of recovery</measure>
    <time_frame>After 12 and after 16 weeks of nutritional follow-up</time_frame>
    <description>Comparaison of the proportion of absence of recovery in SAM children at inclusion between both arms</description>
  </other_outcome>
  <other_outcome>
    <measure>Mortality</measure>
    <time_frame>Through the 6 month study completion</time_frame>
    <description>Comparaison of the death proportion in children with AM at inclusion and in children with SAM at inclusion between both arms in each population</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospitalisation</measure>
    <time_frame>Through the 6 month study completion</time_frame>
    <description>Comparaison of the proportion of hospitalisation in children with AM at inclusion and in children with SAM at inclusion between both arms in each population</description>
  </other_outcome>
  <other_outcome>
    <measure>Relapse to a new episode of AM and to a new episode of SAM</measure>
    <time_frame>During a 3 months period following the recovered episode of AM or of SAM at inclusion</time_frame>
    <description>Comparaison of the proportion of children who relapse to a new episode of AM and to a new episode of SAM in SAM children at inclusion and in children with AM at inclusion between both arms in each population</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1071</enrollment>
  <condition>Severe Acute Malnutrition</condition>
  <condition>Moderate Acute Malnutrition</condition>
  <condition>Child Malnutrition</condition>
  <condition>Acute Malnutrition</condition>
  <condition>Congo, The Democratic Republic of the</condition>
  <condition>Africa</condition>
  <condition>Randomized Clinical Trial</condition>
  <arm_group>
    <arm_group_label>OptiMA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The enrolled subjects will follow the nutritional Optima strategy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The enrolled subjects will follow the standard nutritional protocol currently in use in the Democratic Republic of Congo</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutritional Strategy - OptiMA</intervention_name>
    <description>All children with a MUAC&lt;125mm or oedema will be treated with the same RUTF, according to a new dosage table based on the evolution of MUAC and weight during recovery (RUTF dosage prescribed is gradually reduced as weight and MUAC increase).&#xD;
All children will be followed-up for 6 months following randomization. They will have weekly outpatient visit in the health facility until they meet discharge criteria, and then a bimonthly community-based follow-up in their villages (vital &amp; anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated).</description>
    <arm_group_label>OptiMA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Effective nutritional standard strategy</intervention_name>
    <description>Children presenting with MUAC&lt;115 or WHZ&lt;-3 or nutritional oedema, will be treated with RUTF, according to the usual dosage table based on weight at each visit.&#xD;
All children (whether eligible for RUTF or not) will be followed-up for 6 months following randomization. Children eligible for RUTF at randomization will have a weekly outpatient visit in the health facility until they meet discharge criteria, and then a bi-monthly community-based follow-up in their villages (vital &amp; anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated). Children not eligible for RUTF at randomization will benefit from this same monthly community-based follow-up.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be between 6 and 59 months old;&#xD;
&#xD;
          -  Meet one of the acute malnutrition criteria defined as follows: PB &lt; 125mm or ratio&#xD;
             Weight/Size (Z-score) &lt;-3 (WHO standard) or Oedema of grade +, ++;&#xD;
&#xD;
          -  Be resident in the health area where the active screening session takes place;&#xD;
&#xD;
          -  Have the free, informed and signed consent of the child's mother or guardian.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with medical complication or negative appetite test or oedema (grade +++)&#xD;
&#xD;
          -  Children allergic to milk or peanuts;&#xD;
&#xD;
          -  Children suffering from a known chronic pathology such as sickle cell anemia, trisomy&#xD;
             21, congenital heart disease, or neurological condition;&#xD;
&#xD;
          -  Children currently in a malnutrition programme.&#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>SHEPHERD SUSAN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alliance for International Medical Action</affiliation>
  </overall_official>
  <overall_official>
    <last_name>BECQUET RENAUD, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut National de la Santé Et de la Recherche Médicale, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Zone</name>
      <address>
        <city>Kamuesha</city>
        <state>Kasai</state>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Congo, The Democratic Republic of the</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Malnutrition</keyword>
  <keyword>Severe Acute Malnutrition</keyword>
  <keyword>Moderate Acute Malnutrition</keyword>
  <keyword>Child Malnutrition</keyword>
  <keyword>Congo, The Democratic Republic of the</keyword>
  <keyword>Randomized Clinical Trial</keyword>
  <keyword>Africa</keyword>
  <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>
    <mesh_term>Child Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The research findings will be disseminated in peer-reviewed journals, meetings and international conferences.&#xD;
Individual participant data will be accessible through controlled access repositories, after deidentification (text, tables, figures, and appendices).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>SAP : before end of the study on ClinicalTrials.gov Individual participant data : Beginning 6 months and ending 36 months following article publication. After 36 months the data will be available in our University's data warehouse and in co-investigators (Programme National Nutrition of DRC) data warehouse.</ipd_time_frame>
    <ipd_access_criteria>Study Protocol and ICF(both in french) can be shared on request Individual participant data : researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03751475/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>July 19, 2022</submitted>
    <returned>May 25, 2023</returned>
  </pending_results>
  <!-- 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/NCT03751475
org study id: OptiMA-DRC
nct id: NCT03751475
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Acute malnutrition affects 51 million children under the age of 5 worldwide. Malnutrition
      contributes to nearly half of all child deaths each year, with the forms characterized by
      wasting or oedema (acute malnutrition) associated with the highest risk of death.

      Although acute malnutrition is a continuum condition, it is arbitrarily divided into severe
      and moderate acute malnutrition (SAM, MAM) which are managed separately, with programs
      overseen by different UN agencies, and using different protocols and products. Such
      separation complicates delivery of care, contributes to high default and low coverage, and
      creates confusion among caregivers. Often treatment is only available for SAM children
      resulting in lives lost and costly hospitalisation that could be averted if nutritional
      support were available earlier in the wasting process. If we are to reduce the health and
      mortality burden from malnutrition, the effectiveness and cost-effectiveness of current
      protocols need dramatic improvements.

      The dosage of Ready to Use Therapeutic Food (RUTF) for SAM (130-200 kcal/kg/d) has not
      changed since introduction of out-patient protocols in the mid-2000s. Children classified as
      SAM in these protocols are determined by three independent criteria: the presence of
      nutritional oedema or MUAC < 115 mm or weight-height Z score <-3. The RUTF dosage in these
      protocols is paradoxical in that the absolute amount of RUTF prescribed in the initial phases
      of treatment is often less than that given as the child nears recovery, because the number of
      packets in the weekly ration is determined by weight. However, rate of weight gain (g/kg/day)
      is highest in the first two weeks of treatment, and then plateaus - suggesting no benefit of
      increased RUTF amounts in the later phases of treatment. Progressive reduction seems to be a
      more rational use of RUTF.

      The Optimizing treatment for acute MAlnutrition (OptiMA) strategy consists in simplifying
      management of acute malnutrition through the use of a single anthropometric admission
      criterion (mid upper arm circumference [MUAC] < 125 mm or nutritional oedema) - one that best
      captures children's anthropometry related mortality risk- and by optimizing the use of RUTF
      by adapting doses to the nutritional recovery of the child. RUTF doses begin at 170 kcal/kg/d
      for the most severely wasted (MUAC < 115 mm or oedema) and reduce to 75 kcal/kg/d as oedema
      resolves and MUAC increases > 120 mm.

      The investigators hypothesize that this strategy could double the number of children in care
      compared to current SAM programs without substantially increasing the amount of RUTF or
      staffing required while maintaining a recovery rate in line with current programs. OptiMA may
      also improve coverage and reduce the need for hospitalization through early identification of
      malnourished children.

      The investigators propose to conduct a community-based non-inferiority clinical trial with
      individual randomization comparing the OptiMA strategy to the Democratic Republic of Congo
      standard nutritional protocol for SAM. Study children will be randomly assigned to the
      intervention arm or control arm - with children at MUAC < 125 mm or oedema eligible for RUTF
      in the intervention arm and those meeting current WHO SAM definition eligible in the control
      group. All participants will be followed for 9 months post-randomization to assess
      non-inferiority as defined by a composite of three endpoints : alive, acceptable nutritional
      status (MUAC ≥ 125 mm and WHZ >-3, no oedema) and no relapse to acute malnutrition for those
      who were treated with RUTF. The main secondary outcome will assess the non-inferiority of
      OptiMA RUTF dosing (170 kcal/kg/d) in children meeting current WHO SAM criteria compared to
      children with the same criteria in the control arm who will receive 130-200 kcal/kg/d.
The OptiMA strategy proposes a new malnutrition management approach, grounded in 3 main
      principles.

      Firstly, the diagnosis of acute malnutrition is refined to target those at highest mortality
      risk within the CMAM definition of acute malnutrition (WHZ < -2 or MUAC < 125 mm or oedema),
      by targeting treatment to children with a MUAC < 125 mm or oedema. The simplicity of MUAC
      measure allows families to screen children and check for oedema at home and identify
      malnourished children at an earlier stage. The diagnosis is quickly confirmed by clinicians
      at the health center. MUAC progression is also used to monitor recovery and determine
      discharge thus eliminating the discrepancies that occur when both MUAC and WHZ are used to
      diagnose acute malnutrition.

      Secondly, RUTF dosage is rationalized, and calibrated to the child's degree of wasting. The
      WHZ tables and dosing tables are replaced by a single table that determines the child's RUTF
      ration based on MUAC category and weight. Larger rations, on a per kilo basis, are given to
      the most severely malnourished and the ration is reduced as the child progresses to recovery.

      Thirdly, supply chain is simplified to a single RUTF and data management from 2 programs are
      merged into one. This streamlined programme should result in better coverage, a high
      proportion of children detected before MUAC<115 mm, lower RUTF consumption per child and
      fewer acute malnutrition related hospitalisations.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2 parallel arms stratified on site and degree of acute malnutrition. 890 participants for the principal objective 480 participants with severe acute malnutrition for the secondary main objective
primary purpose: Treatment
masking: None (Open Label)
measure: Success rate in each arm
time frame: 6 months after randomization
description: Success is defined by a composite indicator evaluated 6 months post-randomization:
child alive and not acutely malnourished, per the same definition at inclusion : absence of oedema and MUAC ≥125mm and WHZ ≥-3 and
for the duration of the 6-month observation period following randomization, the child does not develop another episode of acute malnutrition applying the same definition at study inclusion.
measure: Recovery rate in participants with severe acute malnutrition (WHO definition)
time frame: After RUTF treatment, through the 6 month study completion
description: The recovery rate is defined by a MUAC≥125 (OptiMA arm) and a MUAC≥125 or a WHZ>-1.5 (Standard Protocol arm) during two consecutive visits, absence of oedema, minimum treatment period of 4 weeks and good clinical condition
measure: Consumption of RUTF
time frame: At the visit of recovery status occuring through the 6 month study completion
description: Comparaison of the median/mean of the total number of RUTF sachet administred between both arms in recovered SAM
measure: Total weight gain and daily weight gain
time frame: At the visit of recovery status occuring through the 6 month study completion
description: Comparaison of the median/mean of the total weight gain in grams and the daily weight gain in g/kg/d between both arms in recovered SAM children
measure: Total MUAC gain and daily MUAC gain
time frame: At the visit of recovery status occuring through the 6 month study completion
description: Comparaison of the median/mean of the total MUAC gain in mm and of the MUAC gain in mm/day in recovered SAM children between both arms
measure: Total length of RUTF treatment
time frame: At the visit of recovery status occuring through the 6 month study completion
description: Comparaison of the median/mean of the total number of days with RUTF treatment in recovered SAM children between both arms.
measure: Absence of recovery
time frame: After 12 and after 16 weeks of nutritional follow-up
description: Comparaison of the proportion of absence of recovery in SAM children at inclusion between both arms
measure: Mortality
time frame: Through the 6 month study completion
description: Comparaison of the death proportion in children with AM at inclusion and in children with SAM at inclusion between both arms in each population
measure: Hospitalisation
time frame: Through the 6 month study completion
description: Comparaison of the proportion of hospitalisation in children with AM at inclusion and in children with SAM at inclusion between both arms in each population
measure: Relapse to a new episode of AM and to a new episode of SAM
time frame: During a 3 months period following the recovered episode of AM or of SAM at inclusion
description: Comparaison of the proportion of children who relapse to a new episode of AM and to a new episode of SAM in SAM children at inclusion and in children with AM at inclusion between both arms in each population
arm group label: OptiMA
arm group type: Experimental
description: The enrolled subjects will follow the nutritional Optima strategy.
arm group label: Control
arm group type: Active Comparator
description: The enrolled subjects will follow the standard nutritional protocol currently in use in the Democratic Republic of Congo
intervention type: Other
intervention name: Nutritional Strategy - OptiMA
description: All children with a MUAC<125mm or oedema will be treated with the same RUTF, according to a new dosage table based on the evolution of MUAC and weight during recovery (RUTF dosage prescribed is gradually reduced as weight and MUAC increase).
All children will be followed-up for 6 months following randomization. They will have weekly outpatient visit in the health facility until they meet discharge criteria, and then a bimonthly community-based follow-up in their villages (vital & anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated).
arm group label: OptiMA
intervention type: Other
intervention name: Effective nutritional standard strategy
description: Children presenting with MUAC<115 or WHZ<-3 or nutritional oedema, will be treated with RUTF, according to the usual dosage table based on weight at each visit.
All children (whether eligible for RUTF or not) will be followed-up for 6 months following randomization. Children eligible for RUTF at randomization will have a weekly outpatient visit in the health facility until they meet discharge criteria, and then a bi-monthly community-based follow-up in their villages (vital & anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated). Children not eligible for RUTF at randomization will benefit from this same monthly community-based follow-up.
arm group label: Control
criteria: 
gender: All
minimum age: 6 Months
maximum age: 59 Months
healthy volunteers: No
last name: SHEPHERD SUSAN, MD
role: Principal Investigator
affiliation: Alliance for International Medical Action
last name: BECQUET RENAUD, MPH, PhD
role: Principal Investigator
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
facility: 
country: Congo, The Democratic Republic of the
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Severe Acute Malnutrition
mesh term: Child Nutrition Disorders
sharing ipd: Yes
ipd description: The research findings will be disseminated in peer-reviewed journals, meetings and international conferences.
Individual participant data will be accessible through controlled access repositories, after deidentification (text, tables, figures, and appendices).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: SAP : before end of the study on ClinicalTrials.gov Individual participant data : Beginning 6 months and ending 36 months following article publication. After 36 months the data will be available in our University's data warehouse and in co-investigators (Programme National Nutrition of DRC) data warehouse.
ipd access criteria: Study Protocol and ICF(both in french) can be shared on request Individual participant data : researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee
provided document: 
submitted: July 19, 2022
returned: May 25, 2023