<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/NCT03008356</url>
  </required_header>
  <id_info>
    <org_study_id>16-005732</org_study_id>
    <nct_id>NCT03008356</nct_id>
  </id_info>
  <brief_title>L-carnitine for Fatigue in COPD</brief_title>
  <acronym>LC4COPD</acronym>
  <official_title>L-Carnitine Supplementation With and Without Health Coaching for Fatigue in Patients With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      supplementation with L-carnitine that is available both as an FDA-approved therapy for&#xD;
      primary carnitine deficiency, as well as widely available as an over-the-counter ergogenic&#xD;
      aid will improve wellbeing and function measured by questionnaires in patient with chronic&#xD;
      obstructive pulmonary disease (COPD).&#xD;
&#xD;
      based on our review of literature that addition of health coaching (HC) to L-carnitine will&#xD;
      yield greater gains.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT)</measure>
    <time_frame>baseline, end of 8 week intervention</time_frame>
    <description>The 6MWT is a widely studied, standardized and widely utilized test that evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. The self-paced 6MWT assesses the submaximal level of functional capacity. Most patients do not achieve maximal exercise capacity during the 6MWT; instead, they choose their own intensity of exercise and are allowed to stop and rest during the test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Health-Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ)</measure>
    <time_frame>baseline, end of 8 week intervention</time_frame>
    <description>The CRQ is a widely utilized and validated interviewer-administered questionnaire measuring both physical and emotional aspects of chronic respiratory disease. There are 20 questions, with each item graded on 7-point Likert scale. Scores can range from 20 to 100. Higher scores indicate better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Fatigue as Measured by the Chalder Fatigue Questionnaire (CFQ-11)</measure>
    <time_frame>baseline, end of 8 week intervention</time_frame>
    <description>The CFQ-11 is a well-known, widely utilized and validated self-administered questionnaire for measuring the extent and severity of fatigue. The scoring incorporates two self-assessment scales measuring components indicative of physical fatigue [8 items] and mental fatigue [5 items]. The 11 individual items are scored from 0 (better than usual) to 3 (much worse than usual); total score range: 0-33.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity as Measured by the SenseWear Armband</measure>
    <time_frame>end of 8 week intervention</time_frame>
    <description>The SenseWear Armband system (Temple Healthcare) is a versatile arm-band monitor allowing convenient and accurate collection of raw data regarding energy expenditure, sleep duration and quality, physical activity and movement in subjects in a free-living environment, allowing them to go about their normal daily activities. Patients will be shown how to wear the activity monitor and be asked to use it for at least 5 days for 23 hours a day. They will be provided instructions and pre-paid shipping materials for wear and return of the monitor.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Copd</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>L-carnitine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral L-carnitine 1000mg twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>L-carnitine + health coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral L-carnitine 1000mg twice daily and weekly 10-15 minute health coaching calls</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>L-carnitine 1000 mg twice daily</intervention_name>
    <description>Oral L-carnitine to be taken twice daily for 8 weeks</description>
    <arm_group_label>L-carnitine</arm_group_label>
    <arm_group_label>L-carnitine + health coaching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weekly health coaching calls</intervention_name>
    <description>Weekly health coaching calls lasting 10-15 minutes</description>
    <arm_group_label>L-carnitine + health coaching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo capsules</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - COPD patients with a positive screen for fatigue&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Vulnerable population - pregnant women, prisoners, unable to provide consent&#xD;
&#xD;
          -  Pre-menopausal/breastfeeding women (pregnancy category B)&#xD;
&#xD;
          -  Thyroid disease&#xD;
&#xD;
          -  Anticoagulation therapy&#xD;
&#xD;
          -  Decompensated cardiac disease&#xD;
&#xD;
          -  Chronic Kidney Disease (CKD4 or above)&#xD;
&#xD;
          -  Known seizure disorder&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Exacerbation of underlying pulmonary disease or acute illness in the 6 weeks before&#xD;
             screening&#xD;
&#xD;
          -  Enrollment in the past 6 weeks or currently in a cardiac or pulmonary rehab program or&#xD;
             other physical fitness class(es).&#xD;
&#xD;
          -  Difficulty with swallowing pills&#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>Roberto P Benzo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Roberto P. Benzo</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</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/NCT03008356
org study id: 16-005732
nct id: NCT03008356
lead sponsor: 
has dmc: No
supplementation with L-carnitine that is available both as an FDA-approved therapy for
      primary carnitine deficiency, as well as widely available as an over-the-counter ergogenic
      aid will improve wellbeing and function measured by questionnaires in patient with chronic
      obstructive pulmonary disease (COPD).

      based on our review of literature that addition of health coaching (HC) to L-carnitine will
      yield greater gains.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT)
time frame: baseline, end of 8 week intervention
description: The 6MWT is a widely studied, standardized and widely utilized test that evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. The self-paced 6MWT assesses the submaximal level of functional capacity. Most patients do not achieve maximal exercise capacity during the 6MWT; instead, they choose their own intensity of exercise and are allowed to stop and rest during the test.
measure: Change in Health-Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ)
time frame: baseline, end of 8 week intervention
description: The CRQ is a widely utilized and validated interviewer-administered questionnaire measuring both physical and emotional aspects of chronic respiratory disease. There are 20 questions, with each item graded on 7-point Likert scale. Scores can range from 20 to 100. Higher scores indicate better quality of life.
measure: Change in Physical Fatigue as Measured by the Chalder Fatigue Questionnaire (CFQ-11)
time frame: baseline, end of 8 week intervention
description: The CFQ-11 is a well-known, widely utilized and validated self-administered questionnaire for measuring the extent and severity of fatigue. The scoring incorporates two self-assessment scales measuring components indicative of physical fatigue [8 items] and mental fatigue [5 items]. The 11 individual items are scored from 0 (better than usual) to 3 (much worse than usual); total score range: 0-33.
measure: Physical Activity as Measured by the SenseWear Armband
time frame: end of 8 week intervention
description: The SenseWear Armband system (Temple Healthcare) is a versatile arm-band monitor allowing convenient and accurate collection of raw data regarding energy expenditure, sleep duration and quality, physical activity and movement in subjects in a free-living environment, allowing them to go about their normal daily activities. Patients will be shown how to wear the activity monitor and be asked to use it for at least 5 days for 23 hours a day. They will be provided instructions and pre-paid shipping materials for wear and return of the monitor.
arm group label: L-carnitine
arm group type: Experimental
description: Oral L-carnitine 1000mg twice daily
arm group label: L-carnitine + health coaching
arm group type: Experimental
description: Oral L-carnitine 1000mg twice daily and weekly 10-15 minute health coaching calls
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsules twice daily
intervention type: Dietary Supplement
intervention name: L-carnitine 1000 mg twice daily
description: Oral L-carnitine to be taken twice daily for 8 weeks
arm group label: L-carnitine
arm group label: L-carnitine + health coaching
intervention type: Behavioral
intervention name: Weekly health coaching calls
description: Weekly health coaching calls lasting 10-15 minutes
arm group label: L-carnitine + health coaching
intervention type: Dietary Supplement
intervention name: Placebo capsules
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roberto P Benzo
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Roberto P. Benzo
investigator title: PI
mesh term: Fatigue
sharing ipd: No