<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/NCT04476680</url>
  </required_header>
  <id_info>
    <org_study_id>1070MODREC20</org_study_id>
    <nct_id>NCT04476680</nct_id>
  </id_info>
  <brief_title>Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion</brief_title>
  <acronym>IMPACTCOVID</acronym>
  <official_title>Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Centre for Defence Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Leeds Beckett University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liverpool John Moores University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Centre for Defence Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is intended to address the association between vitamin D status and seroconversion&#xD;
      to SARS-CoV-2 in healthy young adults.&#xD;
&#xD;
      The primary aim of the study is to determine the rates of 'silent' seroconversion rates,&#xD;
      consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population&#xD;
      with a wide spread of vitamin D concentrations.&#xD;
&#xD;
      The secondary aims of this study are to explore:&#xD;
&#xD;
        1. Any effect of vitamin D status on symptomatic illness.&#xD;
&#xD;
        2. The background 'point' prevalence and subsequent rate of increase in seropositivity for&#xD;
           SARS-CoV-2 in healthy young adults.&#xD;
&#xD;
        3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in&#xD;
           seropositivity in a defined young adult population over time.&#xD;
&#xD;
        4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/&#xD;
           complementary serological method&#xD;
&#xD;
        5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by:&#xD;
           i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii)&#xD;
           extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of the study is to determine the rates of 'silent' seroconversion rates,&#xD;
      consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population&#xD;
      with a wide spread of vitamin D concentrations.&#xD;
&#xD;
      The study will be conducted over 16 weeks in two populations: Service Personnel undertaking&#xD;
      initial military training, who are supplementing with vitamin D (1000 IU/day D3 for 4 weeks,&#xD;
      and 400 IU/d D3 as a maintenance dose), and civilian students who are not supplementing.&#xD;
&#xD;
      We will recruit adults aged 18-30 years old. Military and civilian participants will be&#xD;
      recruited respectively in Catterick and Leeds, UK to start in coincidence with the&#xD;
      recommencement of Autumn semester.&#xD;
&#xD;
      In accordance with our power calculation and anticipated drop-out rate, 450 volunteers will&#xD;
      be recruited in each group. Data collected at baseline and after 5, 9, 12 and 16 weeks will&#xD;
      include seroconversion status assessed from a validated Dried Blood Spot (DBS) method in&#xD;
      conjunction with novel salivary antibody testing, plus structured questionnaire responses&#xD;
      screening for Covid-19 symptoms. Physical and demographic characteristics and serum levels of&#xD;
      vitamin D concentrations collected from participants at study entry will facilitate secondary&#xD;
      aims in relation to exploring the influence of gender, ethnicity, body mass and body mass&#xD;
      index (BMI) on asymptomatic seroconversion, as well as interactions with vitamin D status and&#xD;
      supplementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">April 28, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Observational study in two cohorts, matched for age and latitude. One group will be taking vitamin D supplements.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seroconversion</measure>
    <time_frame>24 weeks</time_frame>
    <description>asymptomatic seroconversion for SARS-CoV-2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interim analysis - seropositivity at 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>asymptomatic seroconversion for SARS-CoV-2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dried Blood Spot performance</measure>
    <time_frame>24 weeks</time_frame>
    <description>Sensitivity and specificity of dried blood spot assay compared with venous blood serology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary IgA performance</measure>
    <time_frame>24 weeks</time_frame>
    <description>Sensitivity and specificity of salivary IgA compared with venous blood serology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of SARS-CoV-2</measure>
    <time_frame>24 weeks</time_frame>
    <description>The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in seropositivity</measure>
    <time_frame>24 weeks</time_frame>
    <description>The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in seroconversion rate</measure>
    <time_frame>24 weeks</time_frame>
    <description>The effect of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs, iii) gender iv) ethnicity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">900</enrollment>
  <condition>SARS-CoV Infection</condition>
  <condition>Vitamin D Deficiency</condition>
  <condition>Covid19</condition>
  <condition>Acute Respiratory Tract Infection</condition>
  <arm_group>
    <arm_group_label>Military recruits</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vitamin D supplementation (1000 IU/day D3 for 4 weeks, and 400 IU/d D3 as a maintenance dose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>Pure Encapsulations' manufacturing facility is a US Food and Drug Administration (FDA) inspected and NSF International Good Manufacturing Practices registered company.</description>
    <arm_group_label>Military recruits</arm_group_label>
    <other_name>Pure Encapsulations, Sudbury, MA, USA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to access the study sites at Leeds Beckett University's Headingley or City&#xD;
             campuses, UK OR recruit at Infantry Training Centre, Catterick Garrison, UK&#xD;
&#xD;
          -  In possession of an internet-enabled smart phone capable of receiving and responding&#xD;
             to smartphone alerts.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously diagnosed with COVID-19 either by RT-PCR or serologically (either prior to&#xD;
             the study or at initial baseline testing).&#xD;
&#xD;
          -  Use of over-the-counter or prescribed vitamin D supplements currently or in the past&#xD;
             month&#xD;
&#xD;
          -  Condition conferring 'very high risk' or 'high risk' of severe COVID-19&#xD;
&#xD;
               -  have had an organ transplant&#xD;
&#xD;
               -  are having chemotherapy or antibody treatment for cancer, including immunotherapy&#xD;
&#xD;
               -  are having an intense course of radiotherapy (radical radiotherapy) for lung&#xD;
                  cancer&#xD;
&#xD;
               -  are having targeted cancer treatments that can affect the immune system (such as&#xD;
                  protein kinase inhibitors or PARP inhibitors)&#xD;
&#xD;
               -  have blood or bone marrow cancer (such as leukaemia, lymphoma or myeloma)&#xD;
&#xD;
               -  have had a bone marrow or stem cell transplant in the past 6 months, or are still&#xD;
                  taking immunosuppressant medicine&#xD;
&#xD;
               -  are pregnant or intent on becoming pregnant during the anticipated study period&#xD;
&#xD;
               -  have a learning disability&#xD;
&#xD;
               -  have a lung condition (such as cystic fibrosis, asthma, COPD, emphysema or&#xD;
                  bronchitis)&#xD;
&#xD;
               -  have heart disease (such as heart failure)&#xD;
&#xD;
               -  have high blood pressure (hypertension)&#xD;
&#xD;
               -  have diabetes&#xD;
&#xD;
               -  have chronic kidney disease&#xD;
&#xD;
               -  have liver disease (such as hepatitis)&#xD;
&#xD;
               -  have a condition affecting the brain or nerves (such as Parkinson's disease,&#xD;
                  motor neurone disease, multiple sclerosis, or cerebral palsy)&#xD;
&#xD;
               -  have a problem with the spleen or have had the spleen removed&#xD;
&#xD;
               -  have a condition with high risk of getting infections (such as SCID, sickle cell,&#xD;
                  HIV, lupus or scleroderma)&#xD;
&#xD;
               -  are taking medicine that can affect the immune system (such as steroids)&#xD;
&#xD;
               -  are very obese (a BMI of 40 or above)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David R Woods, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Royal Centre of Defence Medicine, Birmingham, UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julie P Greeves, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Army Health and Performance Research, Andover, UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Neil Walsh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liverpool John Moores University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David R Woods, MD</last_name>
    <phone>00441214158660</phone>
    <email>doctordrwoods@aol.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>John O'Hara, PhD</last_name>
    <phone>00441138125239</phone>
    <email>J.OHara@leedsbeckett.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Headingley and City campuses, Leeds Beckett University</name>
      <address>
        <city>Leeds</city>
        <state>Yorkshire</state>
        <zip>LS6 3QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>John O'Hara, PhD</last_name>
      <phone>00441138125239</phone>
      <email>J.OHara@leedsbeckett.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Infantry Training Centre Catterick</name>
      <address>
        <city>Catterick Garrison</city>
        <zip>DL9 4HH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fiona Koivula, PhD</last_name>
      <phone>00447462817020</phone>
      <email>fiona.koivula928@mod.gov.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Cholecalciferol</keyword>
  <keyword>Vitamin D Status</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Acute Respiratory Tract Infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Anonymised IPD may be available upon request</ipd_description>
  </patient_data>
  <!-- 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/NCT04476680
org study id: 1070MODREC20
nct id: NCT04476680
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is intended to address the association between vitamin D status and seroconversion
      to SARS-CoV-2 in healthy young adults.

      The primary aim of the study is to determine the rates of 'silent' seroconversion rates,
      consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population
      with a wide spread of vitamin D concentrations.

      The secondary aims of this study are to explore:

        1. Any effect of vitamin D status on symptomatic illness.

        2. The background 'point' prevalence and subsequent rate of increase in seropositivity for
           SARS-CoV-2 in healthy young adults.

        3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in
           seropositivity in a defined young adult population over time.

        4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/
           complementary serological method

        5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by:
           i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii)
           extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.
The primary aim of the study is to determine the rates of 'silent' seroconversion rates,
      consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population
      with a wide spread of vitamin D concentrations.

      The study will be conducted over 16 weeks in two populations: Service Personnel undertaking
      initial military training, who are supplementing with vitamin D (1000 IU/day D3 for 4 weeks,
      and 400 IU/d D3 as a maintenance dose), and civilian students who are not supplementing.

      We will recruit adults aged 18-30 years old. Military and civilian participants will be
      recruited respectively in Catterick and Leeds, UK to start in coincidence with the
      recommencement of Autumn semester.

      In accordance with our power calculation and anticipated drop-out rate, 450 volunteers will
      be recruited in each group. Data collected at baseline and after 5, 9, 12 and 16 weeks will
      include seroconversion status assessed from a validated Dried Blood Spot (DBS) method in
      conjunction with novel salivary antibody testing, plus structured questionnaire responses
      screening for Covid-19 symptoms. Physical and demographic characteristics and serum levels of
      vitamin D concentrations collected from participants at study entry will facilitate secondary
      aims in relation to exploring the influence of gender, ethnicity, body mass and body mass
      index (BMI) on asymptomatic seroconversion, as well as interactions with vitamin D status and
      supplementation.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Observational study in two cohorts, matched for age and latitude. One group will be taking vitamin D supplements.
primary purpose: Prevention
masking: None (Open Label)
measure: Seroconversion
time frame: 24 weeks
description: asymptomatic seroconversion for SARS-CoV-2
measure: Interim analysis - seropositivity at 12 weeks
time frame: 12 weeks
description: asymptomatic seroconversion for SARS-CoV-2
measure: Dried Blood Spot performance
time frame: 24 weeks
description: Sensitivity and specificity of dried blood spot assay compared with venous blood serology
measure: Salivary IgA performance
time frame: 24 weeks
description: Sensitivity and specificity of salivary IgA compared with venous blood serology
measure: Prevalence of SARS-CoV-2
time frame: 24 weeks
description: The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.
measure: Change in seropositivity
time frame: 24 weeks
description: The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time
measure: Change in seroconversion rate
time frame: 24 weeks
description: The effect of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs, iii) gender iv) ethnicity
arm group label: Military recruits
arm group type: Active Comparator
description: Vitamin D supplementation (1000 IU/day D3 for 4 weeks, and 400 IU/d D3 as a maintenance dose)
arm group label: No intervention
arm group type: No Intervention
intervention type: Dietary Supplement
intervention name: Vitamin D
description: Pure Encapsulations' manufacturing facility is a US Food and Drug Administration (FDA) inspected and NSF International Good Manufacturing Practices registered company.
arm group label: Military recruits
other name: Pure Encapsulations, Sudbury, MA, USA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David R Woods, MD
role: Study Chair
affiliation: Royal Centre of Defence Medicine, Birmingham, UK
last name: Julie P Greeves, PhD
role: Principal Investigator
affiliation: Army Health and Performance Research, Andover, UK
last name: Neil Walsh, PhD
role: Principal Investigator
affiliation: Liverpool John Moores University
last name: David R Woods, MD
phone: 00441214158660
email: doctordrwoods@aol.com
last name: John O'Hara, PhD
phone: 00441138125239
email: J.OHara@leedsbeckett.ac.uk
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Respiratory Tract Infections
mesh term: Severe Acute Respiratory Syndrome
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
sharing ipd: No
ipd description: Anonymised IPD may be available upon request