<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/NCT01666522</url>
  </required_header>
  <id_info>
    <org_study_id>alexmed116671002</org_study_id>
    <nct_id>NCT01666522</nct_id>
  </id_info>
  <brief_title>Vitamin D and Physical Activity for Prevention of Sarcopenia in Osteoporosis</brief_title>
  <official_title>Effect of Vitamin D Supplementation and Physical Activity in Preventing Sarcopenia in Older Adults With Osteoporosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alexandria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alexandria</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the present study the aim was to determine the prevalence of sarcopenia and to evaluate&#xD;
      the effectiveness of an exercise program and vitamin D supplementation in enhancing muscle&#xD;
      mass and strength in community-dwelling older adults with osteopenia /osteoporosis.&#xD;
&#xD;
      One hundred and forty-five individuals aged 65 years and above with documented&#xD;
      osteopenia/osteoporosis were scanned for sarcopenia. The participants were randomly assigned&#xD;
      to one of four groups: Group 1-PA and vitamin D (n= 38), Group 2-PA(n=36), Group 3-vitamin D&#xD;
      (n= 36) or Group 4-healthy lifestyle(n =35) for 16 weeks. The PA group received a 60-minute&#xD;
      3-day/week exercise programme, the vitamin D group received oral cholecalciferol 2000 IU/day&#xD;
      and the control group was provided with health education using videotaped presentations,&#xD;
      physician talks on topics concerning bone and muscle health. Body composition was measured&#xD;
      DEXA. Vitamin D levels were measured and PA was measured using the Baecke Physical Activity&#xD;
      Questionnaire. Physical performance was assessed using upper limb grip strength, walking&#xD;
      speed and knee extension strength. All data was collected at baseline and at 4 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ageing is associated with changes in body composition and due to the ageing of the&#xD;
      populations and the lessened physical activity (PA), sarcopenia and osteopenia /osteoporosis&#xD;
      are emerging as major health concerns. Lack of PA is a significant risk factor for&#xD;
      sarcopenia. Vitamin D plays an important role on bone and muscle development.&#xD;
&#xD;
      This study was conducted to determine the prevalence of sarcopenia and to evaluate the&#xD;
      effectiveness of PA and vitamin D supplementation in enhancing muscle mass and strength in&#xD;
      community-dwelling older adults with osteopenia /osteoporosis.\ One hundred and forty-five&#xD;
      individuals aged 65 years and above with documented osteopenia/osteoporosis were scanned for&#xD;
      sarcopenia (defined as a relative skeletal muscle index (appendicular skeletal muscle mass&#xD;
      divided by height) below 5.45 kg/m2). The participants were randomly assigned to one of four&#xD;
      groups: Group 1-PA and vitamin D (n= 38), Group 2-PA(n=36), Group 3-vitamin D (n= 36) or&#xD;
      Group 4-healthy lifestyle(n =35) for 16 weeks. The PA group received a 60-minute 3-day/week&#xD;
      exercise programme, the vitamin D group received oral cholecalciferol 2000 IU/day and the&#xD;
      control group was provided with health education using videotaped presentations, physician&#xD;
      talks on topics concerning bone and muscle health. Body composition was measured by dual&#xD;
      energy X-ray absorptiometry (DEXA). Vitamin D levels were measured by Liaison immunoassay. PA&#xD;
      was measured using the Baecke Physical Activity Questionnaire. Physical performance was&#xD;
      assessed using upper limb grip strength, walking speed and knee extension strength. All data&#xD;
      was collected at baseline and at 4 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">August 2011</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>muscle mass change</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle mass change</measure>
    <time_frame>4 months</time_frame>
    <description>To determine change in vitamin D status, fasting blood samples were collected from all participants at baseline and after 16 weeks of intervention and were measured by Liaison immunoassay.&#xD;
Muscle mass change and sarcopenia prevention was measured using the relative skeletal muscle index (appendicular skeletal muscle mass divided by height) below 5.45 kg/m2).</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">145</enrollment>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>Vitamin D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vitamin D-oral cholecalciferol 2000 IU/day for 4 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical activity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 3-day/week exercise programme lasting 60 minutes each day for 4 months was instigated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D and Physical activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vitamin D -oral cholecalciferol 2000 IU/day and Physical activity-60-minute 3-day/week exercise programme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Vitamin D</arm_group_label>
    <arm_group_label>Vitamin D and Physical activity</arm_group_label>
    <other_name>cholecalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical activity</intervention_name>
    <description>Physical activity in the form of an exercise programme consisting of 60 minutes all inclusive warming up , strengthening, resistance and stretching exercises were instigated 3 times a week for 4 months.</description>
    <arm_group_label>Physical activity</arm_group_label>
    <arm_group_label>Vitamin D and Physical activity</arm_group_label>
    <other_name>Exercise programme</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older adults aged 60 and above&#xD;
&#xD;
          -  osteopenia/osteoporosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe cognitive impairment&#xD;
&#xD;
          -  major organ disease&#xD;
&#xD;
          -  current consumption of corticosteroids or vitamin D&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <zip>00203</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 10, 2012</last_update_submitted>
  <last_update_submitted_qc>August 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alexandria</investigator_affiliation>
    <investigator_full_name>Anna Abou-Raya</investigator_full_name>
    <investigator_title>Professor of Rheumatology</investigator_title>
  </responsible_party>
  <keyword>sarcopenia</keyword>
  <keyword>osteopenia/osteoporosis</keyword>
  <keyword>older adults</keyword>
  <keyword>vitamin D supplementation</keyword>
  <keyword>physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Cholecalciferol</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/NCT01666522
org study id: alexmed116671002
nct id: NCT01666522
lead sponsor: 
has dmc: Yes
In the present study the aim was to determine the prevalence of sarcopenia and to evaluate
      the effectiveness of an exercise program and vitamin D supplementation in enhancing muscle
      mass and strength in community-dwelling older adults with osteopenia /osteoporosis.

      One hundred and forty-five individuals aged 65 years and above with documented
      osteopenia/osteoporosis were scanned for sarcopenia. The participants were randomly assigned
      to one of four groups: Group 1-PA and vitamin D (n= 38), Group 2-PA(n=36), Group 3-vitamin D
      (n= 36) or Group 4-healthy lifestyle(n =35) for 16 weeks. The PA group received a 60-minute
      3-day/week exercise programme, the vitamin D group received oral cholecalciferol 2000 IU/day
      and the control group was provided with health education using videotaped presentations,
      physician talks on topics concerning bone and muscle health. Body composition was measured
      DEXA. Vitamin D levels were measured and PA was measured using the Baecke Physical Activity
      Questionnaire. Physical performance was assessed using upper limb grip strength, walking
      speed and knee extension strength. All data was collected at baseline and at 4 months.
Ageing is associated with changes in body composition and due to the ageing of the
      populations and the lessened physical activity (PA), sarcopenia and osteopenia /osteoporosis
      are emerging as major health concerns. Lack of PA is a significant risk factor for
      sarcopenia. Vitamin D plays an important role on bone and muscle development.

      This study was conducted to determine the prevalence of sarcopenia and to evaluate the
      effectiveness of PA and vitamin D supplementation in enhancing muscle mass and strength in
      community-dwelling older adults with osteopenia /osteoporosis.\ One hundred and forty-five
      individuals aged 65 years and above with documented osteopenia/osteoporosis were scanned for
      sarcopenia (defined as a relative skeletal muscle index (appendicular skeletal muscle mass
      divided by height) below 5.45 kg/m2). The participants were randomly assigned to one of four
      groups: Group 1-PA and vitamin D (n= 38), Group 2-PA(n=36), Group 3-vitamin D (n= 36) or
      Group 4-healthy lifestyle(n =35) for 16 weeks. The PA group received a 60-minute 3-day/week
      exercise programme, the vitamin D group received oral cholecalciferol 2000 IU/day and the
      control group was provided with health education using videotaped presentations, physician
      talks on topics concerning bone and muscle health. Body composition was measured by dual
      energy X-ray absorptiometry (DEXA). Vitamin D levels were measured by Liaison immunoassay. PA
      was measured using the Baecke Physical Activity Questionnaire. Physical performance was
      assessed using upper limb grip strength, walking speed and knee extension strength. All data
      was collected at baseline and at 4 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: muscle mass change
time frame: 4 months
measure: Muscle mass change
time frame: 4 months
description: To determine change in vitamin D status, fasting blood samples were collected from all participants at baseline and after 16 weeks of intervention and were measured by Liaison immunoassay.
Muscle mass change and sarcopenia prevention was measured using the relative skeletal muscle index (appendicular skeletal muscle mass divided by height) below 5.45 kg/m2).
arm group label: Vitamin D
arm group type: Experimental
description: vitamin D-oral cholecalciferol 2000 IU/day for 4 months
arm group label: Physical activity
arm group type: Active Comparator
description: A 3-day/week exercise programme lasting 60 minutes each day for 4 months was instigated.
arm group label: Vitamin D and Physical activity
arm group type: Experimental
description: Vitamin D -oral cholecalciferol 2000 IU/day and Physical activity-60-minute 3-day/week exercise programme
arm group label: Control
arm group type: Placebo Comparator
description: The control group was provided with health education using videotaped presentations, physician talks on topics concerning bone and muscle health.
intervention type: Drug
intervention name: Vitamin D
description: vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months
arm group label: Control
arm group label: Vitamin D
arm group label: Vitamin D and Physical activity
other name: cholecalciferol
intervention type: Other
intervention name: Physical activity
description: Physical activity in the form of an exercise programme consisting of 60 minutes all inclusive warming up , strengthening, resistance and stretching exercises were instigated 3 times a week for 4 months.
arm group label: Physical activity
arm group label: Vitamin D and Physical activity
other name: Exercise programme
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: University of Alexandria
investigator full name: Anna Abou-Raya
investigator title: Professor of Rheumatology
mesh term: Osteoporosis
mesh term: Sarcopenia
mesh term: Vitamin D
mesh term: Cholecalciferol