<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/NCT01669915</url>
  </required_header>
  <id_info>
    <org_study_id>2010P-000769</org_study_id>
    <secondary_id>R01AG036755</secondary_id>
    <nct_id>NCT01669915</nct_id>
  </id_info>
  <brief_title>A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline</brief_title>
  <acronym>VITAL-Cog</acronym>
  <official_title>A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</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 25,875 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. This ancillary study is being conducted among participants in VITAL and will&#xD;
      examine whether vitamin D or fish oil is associated with cognitive decline in 3000 older&#xD;
      participants of VITAL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary aim of annual rate of cognitive decline. Secondary aims will be addressed in sub-set&#xD;
      of participants: 1) among participants, African-American race (African-Americans have high&#xD;
      risk of Vitamin D deficiency) modifies effects of vitamin D3 supplementation on cognitive&#xD;
      decline; 2) among a subset of participants, baseline plasma levels of vitamin D and omega-3&#xD;
      fatty acids modify agent effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2011</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">June 8, 2016</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>Change in Global Composite Score for Cognitive Decline</measure>
    <time_frame>Change over two assessments (baseline, 2.8 years).</time_frame>
    <description>We administered by telephone, eight cognitive tests (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or &quot;decline&quot;) over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Episodic Memory Score for Cognitive Decline</measure>
    <time_frame>Change over two assessments (baseline, 2.8 years)</time_frame>
    <description>The outcome measure was change over time (last assessment score minus the baseline assessment score) in the EPISODIC MEMORY SCORE combining z-scores of 4 tests: the immediate and delayed recalls of both the East Boston Memory Test (EBMT) and the Telephone Interview of Cognitive Status (TICS) 10-word list; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or &quot;decline&quot;) over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.01.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Executive Function Score for Cognitive Decline</measure>
    <time_frame>Change over two assessments (baseline, 2.8 years)</time_frame>
    <description>The outcome measure is change over time (last assessment score minus the baseline assessment score) in the EXECUTIVE FUNCTION SCORE combining z-scores of 4 tests: category fluency (animal naming), digit span backwards, and Oral Trails Making Test (OTMT)-Part A and OTMT-Part B; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or &quot;decline&quot;) over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of +0.006.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.</measure>
    <time_frame>Change over two assessments (baseline, 2.8 years)</time_frame>
    <description>Change over time (last assessment score minus the baseline assessment score) on the TICS (0-41 points), a measure of general cognition. A higher value on the TICS represents better cognitive performance; for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.05</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">3424</enrollment>
  <condition>Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>vitamin D3</intervention_name>
    <description>Vitamin D3 (cholecalciferol), 2000 IU per day</description>
    <arm_group_label>ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids</arm_group_label>
    <arm_group_label>ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids</arm_group_label>
    <other_name>cholecalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>omega-3 fatty acids (fish oil)</intervention_name>
    <description>Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).</description>
    <arm_group_label>ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids</arm_group_label>
    <arm_group_label>PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D3 placebo</intervention_name>
    <description>Vitamin D placebo</description>
    <arm_group_label>PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids</arm_group_label>
    <arm_group_label>PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fish oil placebo</intervention_name>
    <description>Fish oil placebo</description>
    <arm_group_label>ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids</arm_group_label>
    <arm_group_label>PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to&#xD;
        participate in this ancillary study:&#xD;
&#xD;
          1. are aged 60 or more&#xD;
&#xD;
          2. have no hearing impairment&#xD;
&#xD;
          3. indicate a willingness on the run-in phase to participate in a cognitive sub-study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>92 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <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>
  <link>
    <url>http://www.vitalstudy.org</url>
    <description>VITAL study website link</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <results_first_submitted>January 8, 2023</results_first_submitted>
  <results_first_submitted_qc>March 30, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2023</results_first_posted>
  <last_update_submitted>March 30, 2023</last_update_submitted>
  <last_update_submitted_qc>March 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2023</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>Jae Hee Kang</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>In this telephone interview ancillary study, participants (NCT01169259) who:1) were aged 60 or more; 2) had no hearing impairment; 3) were willing to participate in a cognitive sub-study (during run-in phase) were included.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids</title>
          <description>ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).</description>
        </group>
        <group group_id="P2">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids</title>
          <description>ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day</description>
        </group>
        <group group_id="P3">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids</title>
          <description>PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).</description>
        </group>
        <group group_id="P4">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids</title>
          <description>PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="844"/>
                <participants group_id="P2" count="866"/>
                <participants group_id="P3" count="855"/>
                <participants group_id="P4" count="859"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="844"/>
                <participants group_id="P2" count="866"/>
                <participants group_id="P3" count="855"/>
                <participants group_id="P4" count="859"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids</title>
          <description>ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).</description>
        </group>
        <group group_id="B2">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids</title>
          <description>ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day</description>
        </group>
        <group group_id="B3">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids</title>
          <description>PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).</description>
        </group>
        <group group_id="B4">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids</title>
          <description>PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="844"/>
            <count group_id="B2" value="866"/>
            <count group_id="B3" value="855"/>
            <count group_id="B4" value="859"/>
            <count group_id="B5" value="3424"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="88"/>
                    <measurement group_id="B4" value="90"/>
                    <measurement group_id="B5" value="388"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="749"/>
                    <measurement group_id="B2" value="751"/>
                    <measurement group_id="B3" value="767"/>
                    <measurement group_id="B4" value="769"/>
                    <measurement group_id="B5" value="3036"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.0" spread="6.0"/>
                    <measurement group_id="B2" value="70.8" spread="5.9"/>
                    <measurement group_id="B3" value="71.1" spread="6.0"/>
                    <measurement group_id="B4" value="70.7" spread="5.7"/>
                    <measurement group_id="B5" value="70.9" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="484"/>
                    <measurement group_id="B2" value="527"/>
                    <measurement group_id="B3" value="503"/>
                    <measurement group_id="B4" value="502"/>
                    <measurement group_id="B5" value="2016"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="360"/>
                    <measurement group_id="B2" value="339"/>
                    <measurement group_id="B3" value="352"/>
                    <measurement group_id="B4" value="357"/>
                    <measurement group_id="B5" value="1408"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Non-Hispanic white</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="595"/>
                    <measurement group_id="B2" value="589"/>
                    <measurement group_id="B3" value="624"/>
                    <measurement group_id="B4" value="621"/>
                    <measurement group_id="B5" value="2429"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="178"/>
                    <measurement group_id="B2" value="209"/>
                    <measurement group_id="B3" value="181"/>
                    <measurement group_id="B4" value="175"/>
                    <measurement group_id="B5" value="743"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic (not African American)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native American/Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other/unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="844"/>
                    <measurement group_id="B2" value="866"/>
                    <measurement group_id="B3" value="855"/>
                    <measurement group_id="B4" value="859"/>
                    <measurement group_id="B5" value="4218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Global Composite Score for Cognitive Decline</title>
        <description>We administered by telephone, eight cognitive tests (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or &quot;decline&quot;) over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004.</description>
        <time_frame>Change over two assessments (baseline, 2.8 years).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D</title>
            <description>Vitamin D3, one 2000 IU capsule/day</description>
          </group>
          <group group_id="O2">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo</title>
            <description>Vitamin D placebo, one capsule/day</description>
          </group>
          <group group_id="O3">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids</title>
            <description>Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).</description>
          </group>
          <group group_id="O4">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo</title>
            <description>Omega-3 fatty acids placebo, one capsule/day</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Global Composite Score for Cognitive Decline</title>
          <description>We administered by telephone, eight cognitive tests (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or &quot;decline&quot;) over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004.</description>
          <units>Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1710"/>
                <count group_id="O2" value="1714"/>
                <count group_id="O3" value="1699"/>
                <count group_id="O4" value="1725"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="0.01"/>
                    <measurement group_id="O2" value="-0.25" spread="0.01"/>
                    <measurement group_id="O3" value="-0.25" spread="0.01"/>
                    <measurement group_id="O4" value="-0.24" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.31</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 fatty acids active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.14</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.003</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Episodic Memory Score for Cognitive Decline</title>
        <description>The outcome measure was change over time (last assessment score minus the baseline assessment score) in the EPISODIC MEMORY SCORE combining z-scores of 4 tests: the immediate and delayed recalls of both the East Boston Memory Test (EBMT) and the Telephone Interview of Cognitive Status (TICS) 10-word list; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or &quot;decline&quot;) over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.01.</description>
        <time_frame>Change over two assessments (baseline, 2.8 years)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D</title>
            <description>Vitamin D3, one 2000 IU capsule/day</description>
          </group>
          <group group_id="O2">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo</title>
            <description>Vitamin D placebo, one capsule/day</description>
          </group>
          <group group_id="O3">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids</title>
            <description>Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).</description>
          </group>
          <group group_id="O4">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo</title>
            <description>Omega-3 fatty acids placebo, one capsule/day</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Episodic Memory Score for Cognitive Decline</title>
          <description>The outcome measure was change over time (last assessment score minus the baseline assessment score) in the EPISODIC MEMORY SCORE combining z-scores of 4 tests: the immediate and delayed recalls of both the East Boston Memory Test (EBMT) and the Telephone Interview of Cognitive Status (TICS) 10-word list; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or &quot;decline&quot;) over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.01.</description>
          <units>Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1710"/>
                <count group_id="O2" value="1714"/>
                <count group_id="O3" value="1699"/>
                <count group_id="O4" value="1725"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.02"/>
                    <measurement group_id="O2" value="-0.02" spread="0.02"/>
                    <measurement group_id="O3" value="-0.03" spread="0.02"/>
                    <measurement group_id="O4" value="0.02" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.49</p_value>
            <p_value_desc>Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <p_value_desc>Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>-0.002</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Executive Function Score for Cognitive Decline</title>
        <description>The outcome measure is change over time (last assessment score minus the baseline assessment score) in the EXECUTIVE FUNCTION SCORE combining z-scores of 4 tests: category fluency (animal naming), digit span backwards, and Oral Trails Making Test (OTMT)-Part A and OTMT-Part B; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or &quot;decline&quot;) over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of +0.006.</description>
        <time_frame>Change over two assessments (baseline, 2.8 years)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D</title>
            <description>Vitamin D3, one 2000 IU capsule/day</description>
          </group>
          <group group_id="O2">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo</title>
            <description>Vitamin D placebo, one capsule/day</description>
          </group>
          <group group_id="O3">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids</title>
            <description>Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).</description>
          </group>
          <group group_id="O4">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo</title>
            <description>Omega-3 fatty acids placebo, one capsule/day</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Executive Function Score for Cognitive Decline</title>
          <description>The outcome measure is change over time (last assessment score minus the baseline assessment score) in the EXECUTIVE FUNCTION SCORE combining z-scores of 4 tests: category fluency (animal naming), digit span backwards, and Oral Trails Making Test (OTMT)-Part A and OTMT-Part B; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or &quot;decline&quot;) over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of +0.006.</description>
          <units>Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1710"/>
                <count group_id="O2" value="1714"/>
                <count group_id="O3" value="1699"/>
                <count group_id="O4" value="1725"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.48" spread="0.02"/>
                    <measurement group_id="O2" value="-0.48" spread="0.02"/>
                    <measurement group_id="O3" value="-0.47" spread="0.02"/>
                    <measurement group_id="O4" value="-0.49" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.23</p_value>
            <p_value_desc>Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.68</p_value>
            <p_value_desc>Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.003</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.</title>
        <description>Change over time (last assessment score minus the baseline assessment score) on the TICS (0-41 points), a measure of general cognition. A higher value on the TICS represents better cognitive performance; for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.05</description>
        <time_frame>Change over two assessments (baseline, 2.8 years)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D</title>
            <description>Vitamin D3, one 2000 IU capsule/day</description>
          </group>
          <group group_id="O2">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo</title>
            <description>Vitamin D placebo, one capsule/day</description>
          </group>
          <group group_id="O3">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids</title>
            <description>Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).</description>
          </group>
          <group group_id="O4">
            <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo</title>
            <description>Omega-3 fatty acids placebo, one capsule/day</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.</title>
          <description>Change over time (last assessment score minus the baseline assessment score) on the TICS (0-41 points), a measure of general cognition. A higher value on the TICS represents better cognitive performance; for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.05</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1710"/>
                <count group_id="O2" value="1714"/>
                <count group_id="O3" value="1699"/>
                <count group_id="O4" value="1725"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.07"/>
                    <measurement group_id="O2" value="0.07" spread="0.07"/>
                    <measurement group_id="O3" value="0.005" spread="0.07"/>
                    <measurement group_id="O4" value="0.18" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.46</p_value>
            <p_value_desc>Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>-0.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D</title>
          <description>Vitamin D3, one 2000 IU capsule/day</description>
        </group>
        <group group_id="E2">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo</title>
          <description>Vitamin D placebo, one capsule/day</description>
        </group>
        <group group_id="E3">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids</title>
          <description>Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).</description>
        </group>
        <group group_id="E4">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo</title>
          <description>Omega-3 fatty acids placebo, one capsule/day</description>
        </group>
        <group group_id="E5">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D/Active Omega-3 Fatty Acids</title>
          <description>Vitamin D3 (one 2000 IU capsule/day) + Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).</description>
        </group>
        <group group_id="E6">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D/Placebo Omega-3 Fatty Acids</title>
          <description>Vitamin D3, one 2000 IU capsule/day + Omega-3 fatty acids placebo, one capsule/day</description>
        </group>
        <group group_id="E7">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Placebo Vitamin D/Active Omega-3 Fatty Acids</title>
          <description>Vitamin D placebo, one capsule/day + Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).</description>
        </group>
        <group group_id="E8">
          <title>TELEPHONE INTERVIEW ANCILLARY STUDY: Placebo Vitamin D/Placebo Omega-3 Fatty Acids</title>
          <description>Vitamin D placebo, one capsule/day + Omega-3 fatty acids placebo, one capsule/day</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="1710"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="1714"/>
                <counts group_id="E3" subjects_affected="42" subjects_at_risk="1699"/>
                <counts group_id="E4" subjects_affected="25" subjects_at_risk="1725"/>
                <counts group_id="E5" subjects_affected="26" subjects_at_risk="844"/>
                <counts group_id="E6" subjects_affected="15" subjects_at_risk="866"/>
                <counts group_id="E7" subjects_affected="16" subjects_at_risk="855"/>
                <counts group_id="E8" subjects_affected="10" subjects_at_risk="859"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="138" subjects_at_risk="1710"/>
                <counts group_id="E2" subjects_affected="117" subjects_at_risk="1714"/>
                <counts group_id="E3" subjects_affected="134" subjects_at_risk="1699"/>
                <counts group_id="E4" subjects_affected="121" subjects_at_risk="1725"/>
                <counts group_id="E5" subjects_affected="74" subjects_at_risk="844"/>
                <counts group_id="E6" subjects_affected="64" subjects_at_risk="866"/>
                <counts group_id="E7" subjects_affected="60" subjects_at_risk="855"/>
                <counts group_id="E8" subjects_affected="57" subjects_at_risk="859"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="1710"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1714"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="1699"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="1725"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="844"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="866"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="855"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="859"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Major cardiovascular event</sub_title>
                <counts group_id="E1" events="37" subjects_affected="37" subjects_at_risk="1710"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="1714"/>
                <counts group_id="E3" events="35" subjects_affected="35" subjects_at_risk="1699"/>
                <counts group_id="E4" events="24" subjects_affected="24" subjects_at_risk="1725"/>
                <counts group_id="E5" events="24" subjects_affected="24" subjects_at_risk="844"/>
                <counts group_id="E6" events="13" subjects_affected="13" subjects_at_risk="866"/>
                <counts group_id="E7" events="11" subjects_affected="11" subjects_at_risk="855"/>
                <counts group_id="E8" events="11" subjects_affected="11" subjects_at_risk="859"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal bleeding</sub_title>
                <description>Gastrointestinal bleeding</description>
                <counts group_id="E1" events="25" subjects_affected="25" subjects_at_risk="1710"/>
                <counts group_id="E2" events="33" subjects_affected="33" subjects_at_risk="1714"/>
                <counts group_id="E3" events="34" subjects_affected="34" subjects_at_risk="1699"/>
                <counts group_id="E4" events="24" subjects_affected="24" subjects_at_risk="1725"/>
                <counts group_id="E5" events="14" subjects_affected="14" subjects_at_risk="844"/>
                <counts group_id="E6" events="11" subjects_affected="11" subjects_at_risk="866"/>
                <counts group_id="E7" events="20" subjects_affected="20" subjects_at_risk="855"/>
                <counts group_id="E8" events="13" subjects_affected="13" subjects_at_risk="859"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <description>Death</description>
                <counts group_id="E1" events="41" subjects_affected="41" subjects_at_risk="1710"/>
                <counts group_id="E2" events="26" subjects_affected="26" subjects_at_risk="1714"/>
                <counts group_id="E3" events="42" subjects_affected="42" subjects_at_risk="1699"/>
                <counts group_id="E4" events="25" subjects_affected="25" subjects_at_risk="1725"/>
                <counts group_id="E5" events="26" subjects_affected="26" subjects_at_risk="844"/>
                <counts group_id="E6" events="15" subjects_affected="15" subjects_at_risk="866"/>
                <counts group_id="E7" events="16" subjects_affected="16" subjects_at_risk="855"/>
                <counts group_id="E8" events="10" subjects_affected="10" subjects_at_risk="859"/>
              </event>
              <event>
                <sub_title>Cancer</sub_title>
                <description>Cancer</description>
                <counts group_id="E1" events="62" subjects_affected="62" subjects_at_risk="1710"/>
                <counts group_id="E2" events="51" subjects_affected="51" subjects_at_risk="1714"/>
                <counts group_id="E3" events="54" subjects_affected="54" subjects_at_risk="1699"/>
                <counts group_id="E4" events="59" subjects_affected="59" subjects_at_risk="1725"/>
                <counts group_id="E5" events="30" subjects_affected="30" subjects_at_risk="844"/>
                <counts group_id="E6" events="32" subjects_affected="32" subjects_at_risk="866"/>
                <counts group_id="E7" events="24" subjects_affected="24" subjects_at_risk="855"/>
                <counts group_id="E8" events="27" subjects_affected="27" subjects_at_risk="859"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1259" subjects_at_risk="1710"/>
                <counts group_id="E2" subjects_affected="1236" subjects_at_risk="1714"/>
                <counts group_id="E3" subjects_affected="1220" subjects_at_risk="1699"/>
                <counts group_id="E4" subjects_affected="1275" subjects_at_risk="1725"/>
                <counts group_id="E5" subjects_affected="600" subjects_at_risk="844"/>
                <counts group_id="E6" subjects_affected="659" subjects_at_risk="866"/>
                <counts group_id="E7" subjects_affected="620" subjects_at_risk="855"/>
                <counts group_id="E8" subjects_affected="616" subjects_at_risk="859"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Easy bruising</sub_title>
                <counts group_id="E1" events="432" subjects_affected="432" subjects_at_risk="1710"/>
                <counts group_id="E2" events="411" subjects_affected="411" subjects_at_risk="1714"/>
                <counts group_id="E3" events="429" subjects_affected="429" subjects_at_risk="1699"/>
                <counts group_id="E4" events="414" subjects_affected="414" subjects_at_risk="1725"/>
                <counts group_id="E5" events="213" subjects_affected="213" subjects_at_risk="844"/>
                <counts group_id="E6" events="219" subjects_affected="219" subjects_at_risk="866"/>
                <counts group_id="E7" events="216" subjects_affected="216" subjects_at_risk="855"/>
                <counts group_id="E8" events="195" subjects_affected="195" subjects_at_risk="859"/>
              </event>
              <event>
                <sub_title>Frequent nosebleeds</sub_title>
                <counts group_id="E1" events="43" subjects_affected="43" subjects_at_risk="1710"/>
                <counts group_id="E2" events="56" subjects_affected="56" subjects_at_risk="1714"/>
                <counts group_id="E3" events="50" subjects_affected="50" subjects_at_risk="1699"/>
                <counts group_id="E4" events="49" subjects_affected="49" subjects_at_risk="1725"/>
                <counts group_id="E5" events="23" subjects_affected="23" subjects_at_risk="844"/>
                <counts group_id="E6" events="20" subjects_affected="20" subjects_at_risk="866"/>
                <counts group_id="E7" events="27" subjects_affected="27" subjects_at_risk="855"/>
                <counts group_id="E8" events="29" subjects_affected="29" subjects_at_risk="859"/>
              </event>
              <event>
                <sub_title>Blood in urine</sub_title>
                <counts group_id="E1" events="79" subjects_affected="79" subjects_at_risk="1710"/>
                <counts group_id="E2" events="81" subjects_affected="81" subjects_at_risk="1714"/>
                <counts group_id="E3" events="88" subjects_affected="88" subjects_at_risk="1699"/>
                <counts group_id="E4" events="72" subjects_affected="72" subjects_at_risk="1725"/>
                <counts group_id="E5" events="41" subjects_affected="41" subjects_at_risk="844"/>
                <counts group_id="E6" events="38" subjects_affected="38" subjects_at_risk="866"/>
                <counts group_id="E7" events="47" subjects_affected="47" subjects_at_risk="855"/>
                <counts group_id="E8" events="34" subjects_affected="34" subjects_at_risk="859"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Parathyroid condition</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1710"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="1714"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="1699"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="1725"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="844"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="866"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="855"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="859"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Stomach upset of pain</sub_title>
                <counts group_id="E1" events="513" subjects_affected="513" subjects_at_risk="1710"/>
                <counts group_id="E2" events="487" subjects_affected="487" subjects_at_risk="1714"/>
                <counts group_id="E3" events="505" subjects_affected="505" subjects_at_risk="1699"/>
                <counts group_id="E4" events="495" subjects_affected="495" subjects_at_risk="1725"/>
                <counts group_id="E5" events="258" subjects_affected="258" subjects_at_risk="844"/>
                <counts group_id="E6" events="255" subjects_affected="255" subjects_at_risk="866"/>
                <counts group_id="E7" events="247" subjects_affected="247" subjects_at_risk="855"/>
                <counts group_id="E8" events="240" subjects_affected="240" subjects_at_risk="859"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="355" subjects_affected="355" subjects_at_risk="1710"/>
                <counts group_id="E2" events="346" subjects_affected="346" subjects_at_risk="1714"/>
                <counts group_id="E3" events="364" subjects_affected="364" subjects_at_risk="1699"/>
                <counts group_id="E4" events="337" subjects_affected="337" subjects_at_risk="1725"/>
                <counts group_id="E5" events="182" subjects_affected="182" subjects_at_risk="844"/>
                <counts group_id="E6" events="173" subjects_affected="173" subjects_at_risk="866"/>
                <counts group_id="E7" events="182" subjects_affected="182" subjects_at_risk="855"/>
                <counts group_id="E8" events="164" subjects_affected="164" subjects_at_risk="859"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="568" subjects_affected="568" subjects_at_risk="1710"/>
                <counts group_id="E2" events="573" subjects_affected="573" subjects_at_risk="1714"/>
                <counts group_id="E3" events="547" subjects_affected="547" subjects_at_risk="1699"/>
                <counts group_id="E4" events="594" subjects_affected="594" subjects_at_risk="1725"/>
                <counts group_id="E5" events="268" subjects_affected="268" subjects_at_risk="844"/>
                <counts group_id="E6" events="300" subjects_affected="300" subjects_at_risk="866"/>
                <counts group_id="E7" events="279" subjects_affected="279" subjects_at_risk="855"/>
                <counts group_id="E8" events="294" subjects_affected="294" subjects_at_risk="859"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="575" subjects_affected="575" subjects_at_risk="1710"/>
                <counts group_id="E2" events="600" subjects_affected="600" subjects_at_risk="1714"/>
                <counts group_id="E3" events="584" subjects_affected="584" subjects_at_risk="1699"/>
                <counts group_id="E4" events="591" subjects_affected="591" subjects_at_risk="1725"/>
                <counts group_id="E5" events="286" subjects_affected="286" subjects_at_risk="844"/>
                <counts group_id="E6" events="289" subjects_affected="289" subjects_at_risk="866"/>
                <counts group_id="E7" events="298" subjects_affected="298" subjects_at_risk="855"/>
                <counts group_id="E8" events="302" subjects_affected="302" subjects_at_risk="859"/>
              </event>
              <event>
                <sub_title>Increased burping</sub_title>
                <counts group_id="E1" events="229" subjects_affected="229" subjects_at_risk="1710"/>
                <counts group_id="E2" events="251" subjects_affected="251" subjects_at_risk="1714"/>
                <counts group_id="E3" events="240" subjects_affected="240" subjects_at_risk="1699"/>
                <counts group_id="E4" events="240" subjects_affected="240" subjects_at_risk="1725"/>
                <counts group_id="E5" events="109" subjects_affected="109" subjects_at_risk="844"/>
                <counts group_id="E6" events="120" subjects_affected="120" subjects_at_risk="866"/>
                <counts group_id="E7" events="131" subjects_affected="131" subjects_at_risk="855"/>
                <counts group_id="E8" events="120" subjects_affected="120" subjects_at_risk="859"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Bad taste in mouth</sub_title>
                <counts group_id="E1" events="229" subjects_affected="229" subjects_at_risk="1710"/>
                <counts group_id="E2" events="231" subjects_affected="231" subjects_at_risk="1714"/>
                <counts group_id="E3" events="234" subjects_affected="234" subjects_at_risk="1699"/>
                <counts group_id="E4" events="226" subjects_affected="226" subjects_at_risk="1725"/>
                <counts group_id="E5" events="120" subjects_affected="120" subjects_at_risk="844"/>
                <counts group_id="E6" events="109" subjects_affected="109" subjects_at_risk="866"/>
                <counts group_id="E7" events="114" subjects_affected="114" subjects_at_risk="855"/>
                <counts group_id="E8" events="117" subjects_affected="117" subjects_at_risk="859"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney stones</sub_title>
                <counts group_id="E1" events="24" subjects_affected="24" subjects_at_risk="1710"/>
                <counts group_id="E2" events="25" subjects_affected="25" subjects_at_risk="1714"/>
                <counts group_id="E3" events="24" subjects_affected="24" subjects_at_risk="1699"/>
                <counts group_id="E4" events="25" subjects_affected="25" subjects_at_risk="1725"/>
                <counts group_id="E5" events="12" subjects_affected="12" subjects_at_risk="844"/>
                <counts group_id="E6" events="12" subjects_affected="12" subjects_at_risk="866"/>
                <counts group_id="E7" events="12" subjects_affected="12" subjects_at_risk="855"/>
                <counts group_id="E8" events="13" subjects_affected="13" subjects_at_risk="859"/>
              </event>
              <event>
                <sub_title>Kidney failure or dialysis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="1710"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="1714"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="1699"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="1725"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="844"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="866"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="855"/>
                <counts group_id="E8" events="5" subjects_affected="5" subjects_at_risk="859"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin rash</sub_title>
                <counts group_id="E1" events="352" subjects_affected="352" subjects_at_risk="1710"/>
                <counts group_id="E2" events="361" subjects_affected="361" subjects_at_risk="1714"/>
                <counts group_id="E3" events="344" subjects_affected="344" subjects_at_risk="1699"/>
                <counts group_id="E4" events="369" subjects_affected="369" subjects_at_risk="1725"/>
                <counts group_id="E5" events="165" subjects_affected="165" subjects_at_risk="844"/>
                <counts group_id="E6" events="187" subjects_affected="187" subjects_at_risk="866"/>
                <counts group_id="E7" events="179" subjects_affected="179" subjects_at_risk="855"/>
                <counts group_id="E8" events="182" subjects_affected="182" subjects_at_risk="859"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jae Hee Kang</name_or_title>
      <organization>Brigham and Women's Hospital;181 Longwood Ave; Boston, MA 02115</organization>
      <phone>617-525-2022</phone>
      <email>nhjhk@channing.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01669915
org study id: 2010P-000769
secondary id: R01AG036755
nct id: NCT01669915
lead sponsor: 
collaborator: 
has dmc: No
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial
      in 25,875 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 is associated with cognitive decline in 3000 older
      participants of VITAL.
Primary aim of annual rate of cognitive decline. Secondary aims will be addressed in sub-set
      of participants: 1) among participants, African-American race (African-Americans have high
      risk of Vitamin D deficiency) modifies effects of vitamin D3 supplementation on cognitive
      decline; 2) among a subset of participants, baseline plasma levels of vitamin D and omega-3
      fatty acids modify agent effects.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Global Composite Score for Cognitive Decline
time frame: Change over two assessments (baseline, 2.8 years).
description: We administered by telephone, eight cognitive tests (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004.
measure: Change in Episodic Memory Score for Cognitive Decline
time frame: Change over two assessments (baseline, 2.8 years)
description: The outcome measure was change over time (last assessment score minus the baseline assessment score) in the EPISODIC MEMORY SCORE combining z-scores of 4 tests: the immediate and delayed recalls of both the East Boston Memory Test (EBMT) and the Telephone Interview of Cognitive Status (TICS) 10-word list; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.01.
measure: Change in Executive Function Score for Cognitive Decline
time frame: Change over two assessments (baseline, 2.8 years)
description: The outcome measure is change over time (last assessment score minus the baseline assessment score) in the EXECUTIVE FUNCTION SCORE combining z-scores of 4 tests: category fluency (animal naming), digit span backwards, and Oral Trails Making Test (OTMT)-Part A and OTMT-Part B; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of +0.006.
measure: Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.
time frame: Change over two assessments (baseline, 2.8 years)
description: Change over time (last assessment score minus the baseline assessment score) on the TICS (0-41 points), a measure of general cognition. A higher value on the TICS represents better cognitive performance; for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.05
arm group label: ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids
arm group type: Active Comparator
description: ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
arm group label: ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids
arm group type: Active Comparator
description: ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
arm group label: PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids
arm group type: Active Comparator
description: PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
arm group label: PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids
arm group type: Placebo Comparator
description: PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
intervention type: Dietary Supplement
intervention name: vitamin D3
description: Vitamin D3 (cholecalciferol), 2000 IU per day
arm group label: ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids
arm group label: ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids
other name: cholecalciferol
intervention type: Drug
intervention name: omega-3 fatty acids (fish oil)
description: Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
arm group label: ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids
arm group label: PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids
intervention type: Dietary Supplement
intervention name: Vitamin D3 placebo
description: Vitamin D placebo
arm group label: PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids
arm group label: PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids
intervention type: Dietary Supplement
intervention name: Fish oil placebo
description: Fish oil placebo
arm group label: ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids
arm group label: PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids
criteria: 
gender: All
minimum age: 60 Years
maximum age: 92 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
url: http://www.vitalstudy.org
description: VITAL study website link
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Jae Hee Kang
investigator title: Assistant Professor of Medicine
mesh term: Cognitive Dysfunction
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 