<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/NCT03302949</url>
  </required_header>
  <id_info>
    <org_study_id>1004</org_study_id>
    <nct_id>NCT03302949</nct_id>
  </id_info>
  <brief_title>Treating Tuberculosis Wasting With a High-protein Supplement</brief_title>
  <acronym>NUTRIATO</acronym>
  <official_title>Nutritional Supplement Trial in Patients With Tuberculosis to Improve Anthropometry and Treatment Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bandim Health Project</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arla Foods</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</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>
      Undernutrition at the time of diagnosis of active tuberculosis is a risk factor for increased&#xD;
      mortality, and lack of weight gain during anti-tuberculous treatment has been linked to an&#xD;
      increased relapse risk. The purpose of this study is to test the effect of Lacprodan® DI-8090&#xD;
      whey protein concentrate on anthropometric measures, treatment outcome and health-related&#xD;
      quality of life, against standard practice during anti-tuberculous treatment on patients with&#xD;
      a BMI &lt;20 living in Guinea-Bissau.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is hypothesized that patients with tuberculosis receiving whey protein concentrate as&#xD;
      nutritional supplement will experience a greater gain in adverse anthropometric measures, and&#xD;
      experience a decreased risk of relapse and death, compared with patients with tuberculosis,&#xD;
      who do not receive nutritional supplement. 260 patients will be recruited from and&#xD;
      included/randomized at 4 trial sites in Bissau, Guinea-Bissau (Bandim Health Center, Belem&#xD;
      Health Center, Cuntum Health Center and Hospital Raoul Follereau). Patients randomized to the&#xD;
      intervention arm will receive one package of whey protein concentrate (approx. 62.5g) per day&#xD;
      for the duration of the 6-month long anti-tuberculous treatment. Patients will be followed&#xD;
      bimonthly during the treatment period, with clinical examinations, blood sample analyses, and&#xD;
      nutritional status and dietary intake assessments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study enrollment stopped before reaching sample size due to time constraints. Follow up visits&#xD;
    and intervention was given per protocol to all included participants.&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">January 30, 2023</completion_date>
  <primary_completion_date type="Actual">November 1, 2022</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anthropometry</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of patients with BMI gain &gt;9% at end of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment Outcome</measure>
    <time_frame>6 months</time_frame>
    <description>Defined by WHO criteria (incl. mortality), at end of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment outcome</measure>
    <time_frame>2 years</time_frame>
    <description>Defined by WHO criteria (incl. mortality), at 2-year follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometry</measure>
    <time_frame>2 years</time_frame>
    <description>Proportion of patients with sustained BMI gain &gt;9% at 2-year follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet</measure>
    <time_frame>6 months</time_frame>
    <description>Assesment of daily energy intake (kJ) of patients with tuberculosis using sq-FFQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>Score obtained from SF-36</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">232</enrollment>
  <condition>Tuberculosis</condition>
  <condition>Tuberculosis, Pulmonary</condition>
  <condition>Undernutrition</condition>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control arm will not receive the intervention, but will receive standard 6-month anti-tuberculosis regimen and nutritional supplements provided by various NGO's (on irregular basis).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention arm will receive standard 6-month anti-tuberculosis regimen, nutritional supplements provided by various NGO's (on irregular basis), and receive the study intervention of daily supplement of 62.5g Lacprodan® DI-8090</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lacprodan® DI-8090</intervention_name>
    <description>Whey protein concentrate. 100g powder contains 392 kcal (1646 kJ), hereof 80% protein.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with TB&#xD;
&#xD;
          -  Aged 18 years and above&#xD;
&#xD;
          -  BMI&lt;20&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Commencement of treatment ≥30 days prior to inclusion&#xD;
&#xD;
          -  Decreased kidney function&#xD;
&#xD;
          -  Missing informed consent&#xD;
&#xD;
          -  Mentally ill/disabled patients unable to comply with the treatment/intervention&#xD;
             regimen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cecilie B Patsche</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aarhus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Bandim Health Project</name>
      <address>
        <city>Bissau</city>
        <state>Denmark</state>
        <zip>1004</zip>
        <country>Guinea-Bissau</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Guinea-Bissau</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nutritional Supplement</keyword>
  <keyword>Health-related Quality of Life</keyword>
  <keyword>Dietary Intake</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Pulmonary</mesh_term>
    <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/NCT03302949
org study id: 1004
nct id: NCT03302949
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Undernutrition at the time of diagnosis of active tuberculosis is a risk factor for increased
      mortality, and lack of weight gain during anti-tuberculous treatment has been linked to an
      increased relapse risk. The purpose of this study is to test the effect of Lacprodan® DI-8090
      whey protein concentrate on anthropometric measures, treatment outcome and health-related
      quality of life, against standard practice during anti-tuberculous treatment on patients with
      a BMI <20 living in Guinea-Bissau.
It is hypothesized that patients with tuberculosis receiving whey protein concentrate as
      nutritional supplement will experience a greater gain in adverse anthropometric measures, and
      experience a decreased risk of relapse and death, compared with patients with tuberculosis,
      who do not receive nutritional supplement. 260 patients will be recruited from and
      included/randomized at 4 trial sites in Bissau, Guinea-Bissau (Bandim Health Center, Belem
      Health Center, Cuntum Health Center and Hospital Raoul Follereau). Patients randomized to the
      intervention arm will receive one package of whey protein concentrate (approx. 62.5g) per day
      for the duration of the 6-month long anti-tuberculous treatment. Patients will be followed
      bimonthly during the treatment period, with clinical examinations, blood sample analyses, and
      nutritional status and dietary intake assessments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Anthropometry
time frame: 6 months
description: Proportion of patients with BMI gain >9% at end of treatment
measure: Treatment Outcome
time frame: 6 months
description: Defined by WHO criteria (incl. mortality), at end of treatment
measure: Treatment outcome
time frame: 2 years
description: Defined by WHO criteria (incl. mortality), at 2-year follow up
measure: Anthropometry
time frame: 2 years
description: Proportion of patients with sustained BMI gain >9% at 2-year follow up
measure: Diet
time frame: 6 months
description: Assesment of daily energy intake (kJ) of patients with tuberculosis using sq-FFQ
measure: Health-related quality of life
time frame: 6 months
description: Score obtained from SF-36
arm group label: Control
arm group type: No Intervention
description: Control arm will not receive the intervention, but will receive standard 6-month anti-tuberculosis regimen and nutritional supplements provided by various NGO's (on irregular basis).
arm group label: Intervention
arm group type: Experimental
description: Intervention arm will receive standard 6-month anti-tuberculosis regimen, nutritional supplements provided by various NGO's (on irregular basis), and receive the study intervention of daily supplement of 62.5g Lacprodan® DI-8090
intervention type: Dietary Supplement
intervention name: Lacprodan® DI-8090
description: Whey protein concentrate. 100g powder contains 392 kcal (1646 kJ), hereof 80% protein.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cecilie B Patsche
role: Principal Investigator
affiliation: University of Aarhus
facility: 
country: Guinea-Bissau
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Tuberculosis, Pulmonary
mesh term: Malnutrition
sharing ipd: No