<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/NCT02221596</url>
  </required_header>
  <id_info>
    <org_study_id>1R21AG046762-01A1</org_study_id>
    <nct_id>NCT02221596</nct_id>
  </id_info>
  <brief_title>Vitamin D and Muscle Metabolic Function</brief_title>
  <official_title>Vitamin D Contribution to Muscle Metabolic Function in Aged Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David Travis Thomas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to identify the magnitude of muscle lipid redistribution and&#xD;
      muscle oxygen use in individuals 60 years old or older following combined treatment of&#xD;
      vitamin D repletion and aerobic training compared to vitamin D repletion alone, aerobic&#xD;
      training alone, or no treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators plan to recruit approximately 56 aged individuals with vitamin D&#xD;
      insufficiency for a 13 week trial. All subjects will be 60 years of age or older.&#xD;
      Participants will be randomized to one of four groups: vitamin D (50,000IU/wk) + aerobic&#xD;
      training (7 days during the 13th week); vitamin D (50,000IU/wk) + normal daily activity&#xD;
      during the 13th week; placebo + aerobic training (7 days during the 13th week); or placebo +&#xD;
      normal daily activity during the 13th week.&#xD;
&#xD;
      Following screening and informed consent process a physical activity questionnaire will be&#xD;
      administered. A blood draw will then be conducted at baseline, midpoint and endpoint.&#xD;
      Collected blood for the purposes of this study will assess vitamin D status (25(OH)D),&#xD;
      parathyroid hormone, ionized calcium, insulin, and a comprehensive metabolic panel. At&#xD;
      baseline and endpoint muscle lipid will be assessed using Magnetic Resonance Spectroscopy and&#xD;
      muscle oxygen consumption will be determined using a novel hybrid diffuse optical instrument&#xD;
      consisting of a near-infrared spectroscopy and a diffuse correlation spectroscopy. In&#xD;
      addition, at each study time point 3 dietary recalls will be completed and physical activity&#xD;
      will be measured using an accelerometer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</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>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>blood measure</measure>
    <time_frame>Change from Baseline in vitamin D at 13 weeks</time_frame>
    <description>vitamin D</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>muscle lipid</measure>
    <time_frame>baseline and 13 weeks after baseline</time_frame>
    <description>Intramyocellular lipid and extramyocellular lipid will be assessed using magnetic resonance spectroscopy and fat segmentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle oxygen consumption</measure>
    <time_frame>baseline and 13 weeks after baseline</time_frame>
    <description>Local muscle tissue oxidative capacity will be measured using a novel hybrid diffuse optical instrument consisting of a near-infrared spectroscopy (NIRS) and a diffuse correlation spectroscopy (DCS)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>vitamin D + aerobic training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vitamin D capsules every weekday (10,000IU/day) and exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vitamin D + no aerobic training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vitamin D capsules every weekday (10,000IU/day) and no exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo + aerobic training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>placebo capsule every weekday and exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo + no aerobic training</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>placebo capsule every weekday and no exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>vitamin D</intervention_name>
    <description>50,000IU/wk of vitamin D3</description>
    <arm_group_label>vitamin D + aerobic training</arm_group_label>
    <arm_group_label>vitamin D + no aerobic training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>aerobic training</intervention_name>
    <description>7 days of treadmill training during the 13th week of study</description>
    <arm_group_label>placebo + aerobic training</arm_group_label>
    <arm_group_label>vitamin D + aerobic training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 60 and older&#xD;
&#xD;
          -  BMI: 18.5-29&#xD;
&#xD;
          -  Communicates fluently in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metal implant not suitable for MRI&#xD;
&#xD;
          -  Any form of hormone replacement therapy&#xD;
&#xD;
          -  Engage in more than 1 hr/week of vigorous activity&#xD;
&#xD;
          -  Participated in a high-intensity resistance or aerobic training program in the last 3&#xD;
             months&#xD;
&#xD;
          -  Lower extremity injury or surgery in the past 3 months&#xD;
&#xD;
          -  Foot sores or bone conditions severely limiting ability to move or perform exercise or&#xD;
             joint pain made worse by mild exercise&#xD;
&#xD;
          -  Diabetes, inflammatory bowel disease, renal disease or uncontrolled hypertension.&#xD;
&#xD;
          -  Currently have or had a history of cardiovascular or pulmonary disease that would&#xD;
             preclude the involvement in the performance of exercise&#xD;
&#xD;
          -  History of myopathy (including congenital myopathies)&#xD;
&#xD;
          -  History of neurological conditions related to spinal derangement, disk disease,&#xD;
             peripheral neuropathies, tremor and rigidity&#xD;
&#xD;
          -  Past medical history of hyperparathyroidism, kidney stones or rhabdomyolysis&#xD;
&#xD;
          -  Currently receiving treatment for vitamin D deficiency&#xD;
&#xD;
          -  Vitamin D level &gt;30ng/mL&#xD;
&#xD;
          -  Currently smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>D. Travis Thomas, Ph.D., RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>March 14, 2018</last_update_submitted>
  <last_update_submitted_qc>March 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>David Travis Thomas</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <keyword>25(OH)D</keyword>
  <keyword>Aerobic training</keyword>
  <keyword>Near-infrared spectroscopy</keyword>
  <keyword>Diffuse correlation spectroscopy</keyword>
  <keyword>MRS</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</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/NCT02221596
org study id: 1R21AG046762-01A1
nct id: NCT02221596
lead sponsor: 
has dmc: No
The purpose of this study is to identify the magnitude of muscle lipid redistribution and
      muscle oxygen use in individuals 60 years old or older following combined treatment of
      vitamin D repletion and aerobic training compared to vitamin D repletion alone, aerobic
      training alone, or no treatment.
The investigators plan to recruit approximately 56 aged individuals with vitamin D
      insufficiency for a 13 week trial. All subjects will be 60 years of age or older.
      Participants will be randomized to one of four groups: vitamin D (50,000IU/wk) + aerobic
      training (7 days during the 13th week); vitamin D (50,000IU/wk) + normal daily activity
      during the 13th week; placebo + aerobic training (7 days during the 13th week); or placebo +
      normal daily activity during the 13th week.

      Following screening and informed consent process a physical activity questionnaire will be
      administered. A blood draw will then be conducted at baseline, midpoint and endpoint.
      Collected blood for the purposes of this study will assess vitamin D status (25(OH)D),
      parathyroid hormone, ionized calcium, insulin, and a comprehensive metabolic panel. At
      baseline and endpoint muscle lipid will be assessed using Magnetic Resonance Spectroscopy and
      muscle oxygen consumption will be determined using a novel hybrid diffuse optical instrument
      consisting of a near-infrared spectroscopy and a diffuse correlation spectroscopy. In
      addition, at each study time point 3 dietary recalls will be completed and physical activity
      will be measured using an accelerometer.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: blood measure
time frame: Change from Baseline in vitamin D at 13 weeks
description: vitamin D
measure: muscle lipid
time frame: baseline and 13 weeks after baseline
description: Intramyocellular lipid and extramyocellular lipid will be assessed using magnetic resonance spectroscopy and fat segmentation.
measure: muscle oxygen consumption
time frame: baseline and 13 weeks after baseline
description: Local muscle tissue oxidative capacity will be measured using a novel hybrid diffuse optical instrument consisting of a near-infrared spectroscopy (NIRS) and a diffuse correlation spectroscopy (DCS)
arm group label: vitamin D + aerobic training
arm group type: Experimental
description: vitamin D capsules every weekday (10,000IU/day) and exercise
arm group label: vitamin D + no aerobic training
arm group type: Active Comparator
description: vitamin D capsules every weekday (10,000IU/day) and no exercise
arm group label: placebo + aerobic training
arm group type: Active Comparator
description: placebo capsule every weekday and exercise
arm group label: placebo + no aerobic training
arm group type: No Intervention
description: placebo capsule every weekday and no exercise
intervention type: Dietary Supplement
intervention name: vitamin D
description: 50,000IU/wk of vitamin D3
arm group label: vitamin D + aerobic training
arm group label: vitamin D + no aerobic training
intervention type: Other
intervention name: aerobic training
description: 7 days of treadmill training during the 13th week of study
arm group label: placebo + aerobic training
arm group label: vitamin D + aerobic training
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: D. Travis Thomas, Ph.D., RD
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: David Travis Thomas
investigator title: Assistant Professor
mesh term: Vitamin D