<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/NCT01730976</url>
  </required_header>
  <id_info>
    <org_study_id>F/N-R13-3217B</org_study_id>
    <secondary_id>SSRF2012-01</secondary_id>
    <nct_id>NCT01730976</nct_id>
  </id_info>
  <brief_title>Asthma in the Elderly: The Role of Vitamin D</brief_title>
  <official_title>Asthma in the Elderly: The Role of Vitamin D</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We will study whether taking vitamin D improves asthma control and spirometric values in&#xD;
      elderly asthmatics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Asthma Control Test (ACT) score</measure>
    <time_frame>Three months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in pulmonary function tests values (FEV1%, etc.)</measure>
    <time_frame>Three months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Serum vitamin D and calcium levels</measure>
    <time_frame>Three months</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Asthma in the Elderly</condition>
  <arm_group>
    <arm_group_label>Vitamin D 2,000 I.U. daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study subjects will take 2,000 I.U. vitamin D daily for three months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D 2,000 I.U.</intervention_name>
    <arm_group_label>Vitamin D 2,000 I.U. daily</arm_group_label>
    <other_name>Vitamin Shoppe</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asthma, age of 65 years old or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current smokers, subjects who smoked more than 10 pack/year, subjects taking digoxin,&#xD;
             subjects with liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michele Columbo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rohr and Columbo Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rohr and Columbo Asthma, Allergy and Immunology Specialists</name>
      <address>
        <city>Bryn Mawr</city>
        <state>Pennsylvania</state>
        <zip>19010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.</investigator_affiliation>
    <investigator_full_name>Michele Columbo, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>asthma, elderly, vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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>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/NCT01730976
org study id: F/N-R13-3217B
secondary id: SSRF2012-01
nct id: NCT01730976
lead sponsor: 
has dmc: No
We will study whether taking vitamin D improves asthma control and spirometric values in
      elderly asthmatics.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in Asthma Control Test (ACT) score
time frame: Three months
measure: Improvement in pulmonary function tests values (FEV1%, etc.)
time frame: Three months
measure: Serum vitamin D and calcium levels
time frame: Three months
arm group label: Vitamin D 2,000 I.U. daily
arm group type: Experimental
description: Study subjects will take 2,000 I.U. vitamin D daily for three months
intervention type: Dietary Supplement
intervention name: Vitamin D 2,000 I.U.
arm group label: Vitamin D 2,000 I.U. daily
other name: Vitamin Shoppe
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Michele Columbo, M.D.
role: Principal Investigator
affiliation: Rohr and Columbo Associates
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
investigator full name: Michele Columbo, M.D.
investigator title: Principal Investigator
mesh term: Asthma
mesh term: Vitamin D
mesh term: Vitamins