<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/NCT01728571</url>
  </required_header>
  <id_info>
    <org_study_id>2010-P-000622</org_study_id>
    <nct_id>NCT01728571</nct_id>
  </id_info>
  <brief_title>LungVITamin D and OmegA-3 Trial (lungVITAL)</brief_title>
  <acronym>lungVITAL</acronym>
  <official_title>LungVITamin D and OmegA-3 Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial&#xD;
      in 25,871 U.S. men and women investigating whether taking daily dietary supplements of&#xD;
      vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of&#xD;
      developing cancer, heart disease, and stroke in people who do not have a prior history of&#xD;
      these illnesses.&#xD;
&#xD;
      This ancillary study is being conducted among participants in VITAL and will examine whether&#xD;
      vitamin D or fish oil reduces respiratory morbidity, including COPD and asthma exacerbations,&#xD;
      the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether&#xD;
      either of these interventions improves asthma control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive lung disease (COPD) and pneumonia are leading causes of death in United&#xD;
      States and worldwide. COPD, which is also a significant source of disability, is increasing&#xD;
      in prevalence. Approximately 14 million adults have asthma, which leads to approximately 12&#xD;
      million missed work days per year in the United States. In adults, COPD and asthma often&#xD;
      coexist. Treatment options for COPD are limited, and prevalence of vitamin D deficiency is&#xD;
      high. COPD lung disease (COPD, asthma, airflow obstruction), and most COPD additional&#xD;
      co-morbidities responsible for COPD progression (e.g., respiratory infections/pneumonia,&#xD;
      muscle weakness, cardiac failure) may benefit from vitamin D supplementation therapy, but&#xD;
      this requires rigorous testing. Marine omega-3 fatty acids work through different pathways&#xD;
      from vitamin D to affect inflammation. Observational studies and clinical trials suggest that&#xD;
      consumption of fish and/or fish oil may protect against COPD, asthma or pneumonia, but the&#xD;
      data are not consistent. Thus, there is a compelling need for a clinical trial to evaluate&#xD;
      the potential benefits or risks of vitamin D and fish oil supplementation on COPD and asthma&#xD;
      exacerbations, airflow obstruction and decline of lung function, and risk of pneumonia.&#xD;
&#xD;
      The primary outcomes of interest in Lung VITAL are COPD exacerbations; airflow obstruction&#xD;
      and decline of pulmonary function; and pneumonia. Asthma exacerbations and asthma control are&#xD;
      secondary outcomes. A tertiary goal is to assess whether the effects of the interventions&#xD;
      differ by baseline dietary intake or baseline blood levels of the nutrients.&#xD;
&#xD;
      Depending on the primary outcome, Lung VITAL will be conducted among all participants in&#xD;
      VITAL (NCT 01169259), or in subsets of the VITAL population who were followed by detailed&#xD;
      respiratory questionnaire and/or lung function testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Anticipated">February 2025</completion_date>
  <primary_completion_date type="Actual">November 10, 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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>COPD exacerbations in the past year over the course of the study</measure>
    <time_frame>at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year</time_frame>
    <description>Baseline respiratory symptom status, respiratory disease diagnoses, and COPD (chronic obstructive pulmonary disease) exacerbations in the past year are measured pre-randomization and annually during follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Airflow obstruction/change in pulmonary function</measure>
    <time_frame>pre-randomization and after 2 years follow-up</time_frame>
    <description>In a sub-group of study participants pulmonary function will be measured pre-randomization and after 2 years of follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pneumonia in the past year over the course of the study</measure>
    <time_frame>at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year</time_frame>
    <description>Pneumonia in the past year (overall and in those with COPD and asthma) is measured pre-randomization and annually during follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asthma exacerbations and asthma control in the past year over the course of the study</measure>
    <time_frame>at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year</time_frame>
    <description>Participants who report an asthma diagnosis are asked questions related to respiratory illness exacerbations and asthma control annually during follow-up.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">25871</enrollment>
  <condition>COPD</condition>
  <condition>Asthma</condition>
  <condition>Pulmonary Function</condition>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>Vitamin D3 + fish oil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D3 + fish oil placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dietary Supplement: vitamin D3 Dietary Supplement: fish oil placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D3 placebo + fish oil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Drug: omega-3 fatty acids (fish oil) Dietary Supplement: vitamin D3 placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D3 placebo + fish oil placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dietary Supplement: vitamin D3 placebo Dietary Supplement: fish oil placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <arm_group_label>Vitamin D3 + fish oil</arm_group_label>
    <arm_group_label>Vitamin D3 + fish oil placebo</arm_group_label>
    <other_name>Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>fish oil</intervention_name>
    <arm_group_label>Vitamin D3 + fish oil</arm_group_label>
    <arm_group_label>Vitamin D3 placebo + fish oil</arm_group_label>
    <other_name>Omacor; 1 g per day as a fish oil capsule, containing 840 milligrams of marine omega-3 fatty acids (460 mg of eicosapentaenoic acid [EPA] and 380 mg of docosahexaenoic acid [DHA]).</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D3 placebo</intervention_name>
    <arm_group_label>Vitamin D3 placebo + fish oil</arm_group_label>
    <arm_group_label>Vitamin D3 placebo + fish oil placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fish oil placebo</intervention_name>
    <arm_group_label>Vitamin D3 + fish oil placebo</arm_group_label>
    <arm_group_label>Vitamin D3 placebo + fish oil placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  This study is open to all VITAL participants (NCT 01169259). Population includes men&#xD;
             50 years of age or older and women 55 years of age or older in the United States&#xD;
&#xD;
          -  Participants who live in selected metropolitan areas of the U.S. (where we set up the&#xD;
             infrastructure for clinic or home visits), are eligible for pulmonary function&#xD;
             measurements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diane R Gold, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>August 11, 2021</last_update_submitted>
  <last_update_submitted_qc>August 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Diane Gold</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>asthma</keyword>
  <keyword>pulmonary function</keyword>
  <keyword>pneumonia</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>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</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/NCT01728571
org study id: 2010-P-000622
nct id: NCT01728571
lead sponsor: 
collaborator: 
has dmc: Yes
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial
      in 25,871 U.S. men and women investigating whether taking daily dietary supplements of
      vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of
      developing cancer, heart disease, and stroke in people who do not have a prior history of
      these illnesses.

      This ancillary study is being conducted among participants in VITAL and will examine whether
      vitamin D or fish oil reduces respiratory morbidity, including COPD and asthma exacerbations,
      the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether
      either of these interventions improves asthma control.
Chronic obstructive lung disease (COPD) and pneumonia are leading causes of death in United
      States and worldwide. COPD, which is also a significant source of disability, is increasing
      in prevalence. Approximately 14 million adults have asthma, which leads to approximately 12
      million missed work days per year in the United States. In adults, COPD and asthma often
      coexist. Treatment options for COPD are limited, and prevalence of vitamin D deficiency is
      high. COPD lung disease (COPD, asthma, airflow obstruction), and most COPD additional
      co-morbidities responsible for COPD progression (e.g., respiratory infections/pneumonia,
      muscle weakness, cardiac failure) may benefit from vitamin D supplementation therapy, but
      this requires rigorous testing. Marine omega-3 fatty acids work through different pathways
      from vitamin D to affect inflammation. Observational studies and clinical trials suggest that
      consumption of fish and/or fish oil may protect against COPD, asthma or pneumonia, but the
      data are not consistent. Thus, there is a compelling need for a clinical trial to evaluate
      the potential benefits or risks of vitamin D and fish oil supplementation on COPD and asthma
      exacerbations, airflow obstruction and decline of lung function, and risk of pneumonia.

      The primary outcomes of interest in Lung VITAL are COPD exacerbations; airflow obstruction
      and decline of pulmonary function; and pneumonia. Asthma exacerbations and asthma control are
      secondary outcomes. A tertiary goal is to assess whether the effects of the interventions
      differ by baseline dietary intake or baseline blood levels of the nutrients.

      Depending on the primary outcome, Lung VITAL will be conducted among all participants in
      VITAL (NCT 01169259), or in subsets of the VITAL population who were followed by detailed
      respiratory questionnaire and/or lung function testing.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: COPD exacerbations in the past year over the course of the study
time frame: at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year
description: Baseline respiratory symptom status, respiratory disease diagnoses, and COPD (chronic obstructive pulmonary disease) exacerbations in the past year are measured pre-randomization and annually during follow-up.
measure: Airflow obstruction/change in pulmonary function
time frame: pre-randomization and after 2 years follow-up
description: In a sub-group of study participants pulmonary function will be measured pre-randomization and after 2 years of follow-up
measure: Pneumonia in the past year over the course of the study
time frame: at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year
description: Pneumonia in the past year (overall and in those with COPD and asthma) is measured pre-randomization and annually during follow-up.
measure: Asthma exacerbations and asthma control in the past year over the course of the study
time frame: at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year
description: Participants who report an asthma diagnosis are asked questions related to respiratory illness exacerbations and asthma control annually during follow-up.
arm group label: Vitamin D3 + fish oil
arm group type: Active Comparator
description: Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil)
arm group label: Vitamin D3 + fish oil placebo
arm group type: Active Comparator
description: Dietary Supplement: vitamin D3 Dietary Supplement: fish oil placebo
arm group label: Vitamin D3 placebo + fish oil
arm group type: Active Comparator
description: Drug: omega-3 fatty acids (fish oil) Dietary Supplement: vitamin D3 placebo
arm group label: Vitamin D3 placebo + fish oil placebo
arm group type: Placebo Comparator
description: Dietary Supplement: vitamin D3 placebo Dietary Supplement: fish oil placebo
intervention type: Dietary Supplement
intervention name: Vitamin D3
arm group label: Vitamin D3 + fish oil
arm group label: Vitamin D3 + fish oil placebo
other name: Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol
intervention type: Dietary Supplement
intervention name: fish oil
arm group label: Vitamin D3 + fish oil
arm group label: Vitamin D3 placebo + fish oil
other name: Omacor; 1 g per day as a fish oil capsule, containing 840 milligrams of marine omega-3 fatty acids (460 mg of eicosapentaenoic acid [EPA] and 380 mg of docosahexaenoic acid [DHA]).
intervention type: Dietary Supplement
intervention name: Vitamin D3 placebo
arm group label: Vitamin D3 placebo + fish oil
arm group label: Vitamin D3 placebo + fish oil placebo
intervention type: Dietary Supplement
intervention name: Fish oil placebo
arm group label: Vitamin D3 + fish oil placebo
arm group label: Vitamin D3 placebo + fish oil placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Diane R Gold, MD, MPH
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Diane Gold
investigator title: Professor of Medicine
mesh term: Pneumonia
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins