<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/NCT03774953</url>
  </required_header>
  <id_info>
    <org_study_id>CAP protein</org_study_id>
    <nct_id>NCT03774953</nct_id>
  </id_info>
  <brief_title>The Effect of Protein Supplement on Lean Body Mass in Patients With Pneumonia</brief_title>
  <acronym>CAPprotein</acronym>
  <official_title>A Randomized, Controlled Clinical Trial on the Effect of Protein Supplement on Lean Body Mass in Patients With Community Acquired Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nordsjaellands Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nordsjaellands Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this clinical trial is to reduce the patient's loss of lean body mass by&#xD;
      protein supplementation during hospitalization and 60 days after hospital discharge. Also,&#xD;
      the study aims to reduce the risk of readmission to the hospital due to relapse or&#xD;
      complications and thereby improving the overall health for the patients.&#xD;
&#xD;
      The intervention group will receive protein supplementation during hospitalization and after&#xD;
      discharge, while the control group will continue their normal diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infections are globally the biggest cause of mortality. In Denmark community acquired&#xD;
      pneumonia is one of the most common causes for infections in patients. Mortality in pneumonia&#xD;
      has been stable high over the past 10 years. Therefore, it is relevant to look at improving&#xD;
      the prognosis of these patients. After a longer period of hospitalization, patients generally&#xD;
      have a poor condition with loss of body weight and lean body mass. Hereafter, patients must&#xD;
      often undergo a longterm rehabilitation period and they become inactive and fatigue.&#xD;
&#xD;
      This is a threat for the patients, due to the fact that there is a higher risk of&#xD;
      complications and readmissions.&#xD;
&#xD;
      Proteins are the body's building blocks. Thus, supplementing patients with a daily higher&#xD;
      protein content, it is believed to reduce their loss of lean body mass, and thereby reduce&#xD;
      the total loss of body weight as well. Protein supplementation together with vitamin- and&#xD;
      mineral supplementation is thought to improve all these health risk markers for the patients.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Inclusion: 40 men and women &gt;60 years hospitalized with community acquired pneumonia&#xD;
      Intervention: The patients will be randomized to either the control- or intervention group.&#xD;
      They will receive the same treatment and care, the only difference is that the patients in&#xD;
      the intervention group will receive protein- and vitamin supplementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Randomized to intervention or control arm</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Loss of Lean Body Mass</measure>
    <time_frame>Change from Baseline lean body mass until 2 months after discharged</time_frame>
    <description>Loss of lean body mass measured by bioimpedance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Loss of Body weight</measure>
    <time_frame>Change from Baseline weight until 2 months after discharged</time_frame>
    <description>Loss of body weight measured by weight scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmissions</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Number of readmissions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay between the two groups</measure>
    <time_frame>From admission until discharge (an average of 5 days)</time_frame>
    <description>Number of days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured by units on a scale</measure>
    <time_frame>Change in individual experiences regards to quality of life from Baseline until 2 months after discharged</time_frame>
    <description>Quality of life measured by units on a scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Normal daily living function</measure>
    <time_frame>Change in physical condition from Baseline until 2 months after discharged</time_frame>
    <description>Normal daily living function measured by units on a scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Community-acquired Pneumonia</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>protein and vitamin supplementation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No supplementations</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Protein and vitamin supplementation</intervention_name>
    <description>The intervention group will receive 1.5 g protein/kilo/day during hospitalization and a standard dose of 27 g protein/day in 60 days after discharged together with a daily dose of vitamin/mineral supplement</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized patients with community acquired pneumonia&#xD;
&#xD;
          -  &gt;60 years&#xD;
&#xD;
          -  Patients who are able to speak and understand Danish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with hospitalized acquired pneumonia&#xD;
&#xD;
          -  Patients with septic shock&#xD;
&#xD;
          -  Patients with an active cancer and in cancer treatment&#xD;
&#xD;
          -  Patients in dialysis&#xD;
&#xD;
          -  ICU patients&#xD;
&#xD;
          -  Patients unable or unwilling to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Birgitte Lindegaard Madsen</last_name>
    <role>Study Director</role>
    <affiliation>Nordsjaellands Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nordsjaellands hospital</name>
      <address>
        <city>Hillerød</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pneumonia</keyword>
  <keyword>community acquired pneumonia</keyword>
  <keyword>protein</keyword>
  <keyword>lean body mass</keyword>
  <keyword>weight loss</keyword>
  <keyword>readmission</keyword>
  <keyword>infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03774953
org study id: CAP protein
nct id: NCT03774953
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this clinical trial is to reduce the patient's loss of lean body mass by
      protein supplementation during hospitalization and 60 days after hospital discharge. Also,
      the study aims to reduce the risk of readmission to the hospital due to relapse or
      complications and thereby improving the overall health for the patients.

      The intervention group will receive protein supplementation during hospitalization and after
      discharge, while the control group will continue their normal diet.
Infections are globally the biggest cause of mortality. In Denmark community acquired
      pneumonia is one of the most common causes for infections in patients. Mortality in pneumonia
      has been stable high over the past 10 years. Therefore, it is relevant to look at improving
      the prognosis of these patients. After a longer period of hospitalization, patients generally
      have a poor condition with loss of body weight and lean body mass. Hereafter, patients must
      often undergo a longterm rehabilitation period and they become inactive and fatigue.

      This is a threat for the patients, due to the fact that there is a higher risk of
      complications and readmissions.

      Proteins are the body's building blocks. Thus, supplementing patients with a daily higher
      protein content, it is believed to reduce their loss of lean body mass, and thereby reduce
      the total loss of body weight as well. Protein supplementation together with vitamin- and
      mineral supplementation is thought to improve all these health risk markers for the patients.

      Methods:

      Inclusion: 40 men and women >60 years hospitalized with community acquired pneumonia
      Intervention: The patients will be randomized to either the control- or intervention group.
      They will receive the same treatment and care, the only difference is that the patients in
      the intervention group will receive protein- and vitamin supplementation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized to intervention or control arm
primary purpose: Treatment
masking: None (Open Label)
measure: Loss of Lean Body Mass
time frame: Change from Baseline lean body mass until 2 months after discharged
description: Loss of lean body mass measured by bioimpedance
measure: Loss of Body weight
time frame: Change from Baseline weight until 2 months after discharged
description: Loss of body weight measured by weight scale
measure: Readmissions
time frame: Up to 6 months
description: Number of readmissions
measure: Length of hospital stay between the two groups
time frame: From admission until discharge (an average of 5 days)
description: Number of days
measure: Quality of life measured by units on a scale
time frame: Change in individual experiences regards to quality of life from Baseline until 2 months after discharged
description: Quality of life measured by units on a scale
measure: Normal daily living function
time frame: Change in physical condition from Baseline until 2 months after discharged
description: Normal daily living function measured by units on a scale
arm group label: Intervention group
arm group type: Experimental
description: protein and vitamin supplementation
arm group label: Control group
arm group type: No Intervention
description: No supplementations
intervention type: Dietary Supplement
intervention name: Protein and vitamin supplementation
description: The intervention group will receive 1.5 g protein/kilo/day during hospitalization and a standard dose of 27 g protein/day in 60 days after discharged together with a daily dose of vitamin/mineral supplement
arm group label: Intervention group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Birgitte Lindegaard Madsen
role: Study Director
affiliation: Nordsjaellands Hospital
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Vitamins