<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/NCT03253055</url>
  </required_header>
  <id_info>
    <org_study_id>D-BIICEP</org_study_id>
    <nct_id>NCT03253055</nct_id>
  </id_info>
  <brief_title>The D-BIICEP Study</brief_title>
  <acronym>D-BIICEP</acronym>
  <official_title>The Interrelationship Between Vitamin D, Bone, Illness, Injury and Its Impact on Exercise Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Surrey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Surrey</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>
      Athletes and active individuals have been identified as an at-risk group for a low vitamin D&#xD;
      status, specifically those residing in countries of higher latitude (such as the United&#xD;
      Kingdom). This especially applies to those who train indoors for their sport, this is because&#xD;
      Vitamin D is primarily produced following skin exposure to ultraviolet B (UVB) exposure.&#xD;
      Vitamin D is essential for the maintenance of optimal bone and musculoskeletal health. It has&#xD;
      also been suggested to play a role in the prevention of illness incidence, such as in upper&#xD;
      respiratory tract infections (URTI). More recent research has indicated that an improved&#xD;
      Vitamin D status may also play a role in enhancing exercise performance. Therefore, having a&#xD;
      poor vitamin D status could negatively impact athletic training and competition. The purpose&#xD;
      of this study is to evaluate the prevalence of vitamin D deficiency in university athletes&#xD;
      and inactive controls in spring and autumn.&#xD;
&#xD;
      During this study the subjects will be asked to visit the labs on two occasions, at the&#xD;
      beginning of the study for baseline measurements, and again on two occasions at the end of&#xD;
      the study. Participants will have the following outcomes assessed: Sport performance&#xD;
      (vertical jump height, muscular strength and aerobic fitness), peripheral Quantitative&#xD;
      Computed Tomography (pQCT) scan of the bone mineral composition of the tibia, total body&#xD;
      composition via Dual Energy X-ray Absorptiometry (DEXA),total and hip/femoral head bone&#xD;
      mineral density and content to assess fracture risk via DEXA. Serum 25(OH)D levels (≈15ml of&#xD;
      whole blood will be collected for these measurements. Dietary intake using self-reported food&#xD;
      diaries. In addition illness and injury incidence will be recorded daily throughout the study&#xD;
      in a booklet provided to the participants.Throughout the trial, the participants will be&#xD;
      contacted via telephone/ email on a monthly basis to discuss any issues and maintain good&#xD;
      communication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During this study the subjects will be asked to visit the labs on 4 different occasions.&#xD;
      There will be two occasions, at the beginning of the study for baseline measurements, and&#xD;
      again on two occasions at the end of the study.&#xD;
&#xD;
      Data collection will take place across two testing sessions (separated by ~24 - 72 hrs) in&#xD;
      the Autumn and Spring period.&#xD;
&#xD;
      Session 1&#xD;
&#xD;
        -  Peripheral Quantitative Computed Tomography (pQCT) scan of the bone mineral composition&#xD;
           of the tibia.&#xD;
&#xD;
        -  Total and percentage lean and fat mass and total bone mineral density via Dual Energy&#xD;
           X-ray Absorptiometry (DEXA).&#xD;
&#xD;
        -  Sport performance: Vertical jump height and maximal oxygen uptake (VO2 max) test.&#xD;
&#xD;
      Session 2&#xD;
&#xD;
        -  Fasting serum 25(OH)D levels, lipid profile, glucose, insulin, serum calcium, albumin,&#xD;
           parathyroid hormone, C- terminal telopeptide (CTX), full blood count, kidney, thyroid&#xD;
           and liver function (≈15ml of whole blood will be collected for these measurements).&#xD;
&#xD;
        -  Collection of self-reported food diaries to assess dietary intake&#xD;
&#xD;
        -  Sport performance: muscular strength&#xD;
&#xD;
      Aerobic fitness will be tested using a VO2 max exercise protocol using a stationary cycle&#xD;
      ergometer, the participants will be expected to perform this to maximal effort or exhaustion.&#xD;
      The test will consist of progressive increments in cycling workload (power output, W) until&#xD;
      volitional fatigue. The test will take about 8 - 12 minutes to complete and is dependent upon&#xD;
      the fitness of the participants. This will take place in the Sport &amp; Exercise Science&#xD;
      laboratories based in the Clinical Investigation Unit (22AX00). All subjects will be&#xD;
      supervised during exercise at all times and will implement an adequate warm-up and cool-down&#xD;
      to minimize the risk of injury. Staff will be on hand throughout the testing trained&#xD;
      adequately in basic life support (including defibrillation).&#xD;
&#xD;
      Muscular strength assessments will be performed at the Surrey Human Performance Institute.&#xD;
      Muscular strength of the knee extensor and handgrip muscles will be determined using an&#xD;
      Isokinetic Dynamometer and a handgrip dynamometer respectively. For each assessment three&#xD;
      maximal effort isometric contractions will be performed and peak torque (nM) and strength&#xD;
      (kg) will be recorded. Muscular power will be assessed through performance of a&#xD;
      countermovement jump (CMJ).&#xD;
&#xD;
      Body composition (absolute and relative amount of lean and fat mass), whole body bone mineral&#xD;
      density and hip and femur bone mineral density will be measured with the use of DEXA (located&#xD;
      in the Sport &amp; Exercise Science laboratories based in the Clinical Investigation Unit). Two&#xD;
      scans will be performed: one for the assessment of whole body bone mineral density and body&#xD;
      composition, and the other scan is performed to specifically assess fracture risk by scanning&#xD;
      the hip and femoral head. Effective exposure doses for these scans are ~8uSv and ~4uSv&#xD;
      respectively. The total effective dose is depending on the size ('thickness' &amp; height) of the&#xD;
      volunteer and is approximately equivalent to the cosmic radiation exposure received in 45min&#xD;
      of a transatlantic flight, or the radiation dose received on eating 80g of Brazil nuts&#xD;
      (Health Protection Agency).&#xD;
&#xD;
      Bone mineral content of the tibia will be assessed using pQCT and this will be correlated to&#xD;
      bone mineral density data obtained from DEXA. One scan will be performed and effective&#xD;
      exposure doses will be between 1.5-1.8uSv which is comparable to 10 min on a transatlantic&#xD;
      flight or one handful of Brazil nuts. The estimated total exposure dose for a single subject&#xD;
      during the entire study is ~28uSv which is the same level of exposure as an average UK&#xD;
      citizen is exposed to over the course of 4 days via background radiation.&#xD;
&#xD;
      Results of the body composition, bone mineral density, jump height, muscular strength,&#xD;
      aerobic fitness (maximal oxygen uptake: VO2max) and dietary intake from the self-reported&#xD;
      food diaries will be made available to the subjects upon request. The results from the blood&#xD;
      analysis will be reported to the subject if there are any health concerns raised. If the&#xD;
      results are within healthy ranges the participants will not be contacted unless specifically&#xD;
      requested for this information. The investigators will not be contacting their GPs if there&#xD;
      are any concerns raised in the study however it will be stressed that participants should&#xD;
      contact a GP to discuss the results found.&#xD;
&#xD;
      Upon commencing the study, the participants will be required to track their incidence of&#xD;
      illness and training habits during the 20-week experimental period between baseline and&#xD;
      conclusion measurements. Throughout this period the incidence of illness and days trained&#xD;
      during the months must be recorded in a check-list booklet, which will be provided. An email&#xD;
      reminder will be sent to prompt all participants to complete these booklets on a daily basis&#xD;
      during the experimental period, this should only take 1-2 minutes every evening. Throughout&#xD;
      the duration of the trial, the participants will be contacted via telephone/ email on a&#xD;
      monthly basis to discuss any issues and maintain good communication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Seasonal Change in the Number of Participants with Deficiency in Vitamin D (according to government cut-off points in the UK and USA) in University Athletes and their Healthy Controls.</measure>
    <time_frame>1 year</time_frame>
    <description>This will be assessed by measuring serum 25(OH)D levels in participants during Autumn and Spring. Vitamin D status will be measured in nmol/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seasonal Change in the Incidence of Injury in University Athletes</measure>
    <time_frame>1 year</time_frame>
    <description>Self reported questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seasonal Change in Bone Mineral Density in University Athletes</measure>
    <time_frame>1 year</time_frame>
    <description>mg/cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seasonal Change in Bone Mineral Content in University Athletes</measure>
    <time_frame>1 year</time_frame>
    <description>mg/cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in vitamin D status due to participation in indoor or outdoor training in university level athletes between Autumn and Spring.</measure>
    <time_frame>1 year</time_frame>
    <description>hours and nmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between autumn and spring and the effects of high, medium and low impact sports on bone mineral density in university athletes</measure>
    <time_frame>1 year</time_frame>
    <description>mg/cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in muscular power throughout an academic sporting season</measure>
    <time_frame>1 year</time_frame>
    <description>Vertical jump: cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in muscular strength throughout an academic sporting season</measure>
    <time_frame>1 year</time_frame>
    <description>hand-grip strength: kg, knee extensor muscular strength: nM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in aerobic fitness throughout an academic sporting season</measure>
    <time_frame>1 year</time_frame>
    <description>ml/kg/min-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the incidence of injury and illness and its correlation with vitamin D status</measure>
    <time_frame>1 year</time_frame>
    <description>Days of illness reported or missed training due to injury</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Male Athletes</arm_group_label>
    <description>DEXA, pQCT, lifestyle questionnaire, muscular strength measurements, aerobic fitness, blood draw and finger prick test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Female Athletes</arm_group_label>
    <description>DEXA, pQCT, lifestyle questionnaire, muscular strength measurements, aerobic fitness, blood draw and finger prick test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>DEXA, pQCT, lifestyle questionnaire, muscular strength measurements, aerobic fitness, blood draw and finger prick test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>DEXA</intervention_name>
    <description>Dual energy X-ray absorptiometry (DEXA): a total of two scans will be performed, one for the assessment of whole body bone mineral density and body composition, and the other scan is performed to specifically assess fracture risk by scanning the hip and femoral head. Effective exposure doses for these scans are ~8uSv and ~4uSv respectively.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Female Athletes</arm_group_label>
    <arm_group_label>Male Athletes</arm_group_label>
    <other_name>DXA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>pQCT</intervention_name>
    <description>A total of one scan will be performed on the non-dominant Tibia, the effective exposure dose will be between 1.5-1.8uSV.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Female Athletes</arm_group_label>
    <arm_group_label>Male Athletes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lifestyle Questionnaire</intervention_name>
    <description>Participants are required to record their lifestyle, diet (5-day self reported), physical activity (IPAQ questionnaire), injury and illness incidence.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Female Athletes</arm_group_label>
    <arm_group_label>Male Athletes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic Fitness</intervention_name>
    <description>Aerobic fitness will be tested using a VO2 max exercise protocol using a stationary cycle ergometer, the participants will be expected to perform this to maximal effort or exhaustion.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Female Athletes</arm_group_label>
    <arm_group_label>Male Athletes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Muscular Strength</intervention_name>
    <description>Muscular strength of the knee extensor and handgrip muscles will be determined using an Isokinetic Dynamometer and a handgrip dynamometer respectively.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Female Athletes</arm_group_label>
    <arm_group_label>Male Athletes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood draw and finger prick test</intervention_name>
    <description>15ml of whole blood will be collected for the measurement of fasting serum 25(OH)D levels, parathyroid hormone, C-terminal telopeptide (CTX) and full blood count</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Female Athletes</arm_group_label>
    <arm_group_label>Male Athletes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Muscular Power</intervention_name>
    <description>Muscular power will be determined using an optical measurement system consisting of a transmitting and receiving bar to determine jump height through the interpretation of jump flight of the participant (reported in cm). The equipment used is an Optojump.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Female Athletes</arm_group_label>
    <arm_group_label>Male Athletes</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma and Serum samples obtained at baseline and visit 2&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited from the university population in Surrey during term-time&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        University athlete inclusion criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Aged 18-30&#xD;
&#xD;
          -  Regularly train/compete for Team Surrey Basketball, Boat Club, Swimming and Waterpolo,&#xD;
             Netball or Rugby (for more than 4 hours/week)&#xD;
&#xD;
          -  In good physical health&#xD;
&#xD;
          -  Have a BMI &gt;18 kg/m2&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
        Control group inclusion criteria:&#xD;
&#xD;
          -  Male or Female&#xD;
&#xD;
          -  Age 18-30&#xD;
&#xD;
          -  Do not use sun beds/ will not be going on a sun holiday/ returning home to a&#xD;
             traditional sun holiday location between February 2017 and October 2017. This is&#xD;
             because the results will be used to represent the Vitamin D status of young sporting&#xD;
             individuals residing within the UK during these seasons.&#xD;
&#xD;
          -  Do not take supplements containing Vitamin D&#xD;
&#xD;
          -  Do not compete for Team Surrey and exercise less than 150 minutes / week.&#xD;
&#xD;
          -  BMI: 18 - 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently receiving treatment for medical conditions that are likely to affect vitamin&#xD;
             D metabolism&#xD;
&#xD;
          -  Hypercalcaemia (&gt;2.5mmol/L)&#xD;
&#xD;
          -  Regular use of sun-beds&#xD;
&#xD;
          -  Having a sun holiday one month prior to commencing the study or plans for a sun&#xD;
             holiday within the study period or will be returning home to a sun holiday location.&#xD;
&#xD;
          -  Use of vitamin supplements containing vitamin D (if the prospective participants&#xD;
             agrees to stop Vitamin D supplementation to join the study, a wash-out period of 8&#xD;
             weeks prior to commencing the trial would be acceptable).&#xD;
&#xD;
          -  Excess alcohol intake for participants aged 18 years (&gt; 21 units for males, &gt; 14 units&#xD;
             for females per week, as per Government guidelines)&#xD;
&#xD;
          -  Those under dietary restriction (except vegetarianism) or following a weight-reducing&#xD;
             diet.&#xD;
&#xD;
          -  Clinically significant haematological abnormalities other than mild anaemia (Hb&#xD;
             &lt;12.0g/dl)&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Pregnant or planning a pregnancy during the study period&#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>Susan Lanham-New, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Head, Department of Nutritional Scienes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Surrey Human Performance Institute</name>
      <address>
        <city>Guildford</city>
        <state>Surrey</state>
        <zip>GU27AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Surrey</name>
      <address>
        <city>Guildford</city>
        <state>Surrey</state>
        <zip>GU27XH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Halliday TM, Peterson NJ, Thomas JJ, Kleppinger K, Hollis BW, Larson-Meyer DE. Vitamin D status relative to diet, lifestyle, injury, and illness in college athletes. Med Sci Sports Exerc. 2011 Feb;43(2):335-43. doi: 10.1249/MSS.0b013e3181eb9d4d.</citation>
    <PMID>20543748</PMID>
  </reference>
  <reference>
    <citation>Close GL, Leckey J, Patterson M, Bradley W, Owens DJ, Fraser WD, Morton JP. The effects of vitamin D(3) supplementation on serum total 25[OH]D concentration and physical performance: a randomised dose-response study. Br J Sports Med. 2013 Jul;47(11):692-6. doi: 10.1136/bjsports-2012-091735. Epub 2013 Feb 14.</citation>
    <PMID>23410885</PMID>
  </reference>
  <reference>
    <citation>Farrokhyar F, Tabasinejad R, Dao D, Peterson D, Ayeni OR, Hadioonzadeh R, Bhandari M. Prevalence of vitamin D inadequacy in athletes: a systematic-review and meta-analysis. Sports Med. 2015 Mar;45(3):365-78. doi: 10.1007/s40279-014-0267-6.</citation>
    <PMID>25277808</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>November 15, 2018</last_update_submitted>
  <last_update_submitted_qc>November 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Surrey</investigator_affiliation>
    <investigator_full_name>Saskia Wilson-Barnes</investigator_full_name>
    <investigator_title>PhD Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Physical Performance</keyword>
  <keyword>Bone</keyword>
  <keyword>Illness</keyword>
  <keyword>Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03253055/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03253055
org study id: D-BIICEP
nct id: NCT03253055
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Athletes and active individuals have been identified as an at-risk group for a low vitamin D
      status, specifically those residing in countries of higher latitude (such as the United
      Kingdom). This especially applies to those who train indoors for their sport, this is because
      Vitamin D is primarily produced following skin exposure to ultraviolet B (UVB) exposure.
      Vitamin D is essential for the maintenance of optimal bone and musculoskeletal health. It has
      also been suggested to play a role in the prevention of illness incidence, such as in upper
      respiratory tract infections (URTI). More recent research has indicated that an improved
      Vitamin D status may also play a role in enhancing exercise performance. Therefore, having a
      poor vitamin D status could negatively impact athletic training and competition. The purpose
      of this study is to evaluate the prevalence of vitamin D deficiency in university athletes
      and inactive controls in spring and autumn.

      During this study the subjects will be asked to visit the labs on two occasions, at the
      beginning of the study for baseline measurements, and again on two occasions at the end of
      the study. Participants will have the following outcomes assessed: Sport performance
      (vertical jump height, muscular strength and aerobic fitness), peripheral Quantitative
      Computed Tomography (pQCT) scan of the bone mineral composition of the tibia, total body
      composition via Dual Energy X-ray Absorptiometry (DEXA),total and hip/femoral head bone
      mineral density and content to assess fracture risk via DEXA. Serum 25(OH)D levels (≈15ml of
      whole blood will be collected for these measurements. Dietary intake using self-reported food
      diaries. In addition illness and injury incidence will be recorded daily throughout the study
      in a booklet provided to the participants.Throughout the trial, the participants will be
      contacted via telephone/ email on a monthly basis to discuss any issues and maintain good
      communication.
During this study the subjects will be asked to visit the labs on 4 different occasions.
      There will be two occasions, at the beginning of the study for baseline measurements, and
      again on two occasions at the end of the study.

      Data collection will take place across two testing sessions (separated by ~24 - 72 hrs) in
      the Autumn and Spring period.

      Session 1

        -  Peripheral Quantitative Computed Tomography (pQCT) scan of the bone mineral composition
           of the tibia.

        -  Total and percentage lean and fat mass and total bone mineral density via Dual Energy
           X-ray Absorptiometry (DEXA).

        -  Sport performance: Vertical jump height and maximal oxygen uptake (VO2 max) test.

      Session 2

        -  Fasting serum 25(OH)D levels, lipid profile, glucose, insulin, serum calcium, albumin,
           parathyroid hormone, C- terminal telopeptide (CTX), full blood count, kidney, thyroid
           and liver function (≈15ml of whole blood will be collected for these measurements).

        -  Collection of self-reported food diaries to assess dietary intake

        -  Sport performance: muscular strength

      Aerobic fitness will be tested using a VO2 max exercise protocol using a stationary cycle
      ergometer, the participants will be expected to perform this to maximal effort or exhaustion.
      The test will consist of progressive increments in cycling workload (power output, W) until
      volitional fatigue. The test will take about 8 - 12 minutes to complete and is dependent upon
      the fitness of the participants. This will take place in the Sport & Exercise Science
      laboratories based in the Clinical Investigation Unit (22AX00). All subjects will be
      supervised during exercise at all times and will implement an adequate warm-up and cool-down
      to minimize the risk of injury. Staff will be on hand throughout the testing trained
      adequately in basic life support (including defibrillation).

      Muscular strength assessments will be performed at the Surrey Human Performance Institute.
      Muscular strength of the knee extensor and handgrip muscles will be determined using an
      Isokinetic Dynamometer and a handgrip dynamometer respectively. For each assessment three
      maximal effort isometric contractions will be performed and peak torque (nM) and strength
      (kg) will be recorded. Muscular power will be assessed through performance of a
      countermovement jump (CMJ).

      Body composition (absolute and relative amount of lean and fat mass), whole body bone mineral
      density and hip and femur bone mineral density will be measured with the use of DEXA (located
      in the Sport & Exercise Science laboratories based in the Clinical Investigation Unit). Two
      scans will be performed: one for the assessment of whole body bone mineral density and body
      composition, and the other scan is performed to specifically assess fracture risk by scanning
      the hip and femoral head. Effective exposure doses for these scans are ~8uSv and ~4uSv
      respectively. The total effective dose is depending on the size ('thickness' & height) of the
      volunteer and is approximately equivalent to the cosmic radiation exposure received in 45min
      of a transatlantic flight, or the radiation dose received on eating 80g of Brazil nuts
      (Health Protection Agency).

      Bone mineral content of the tibia will be assessed using pQCT and this will be correlated to
      bone mineral density data obtained from DEXA. One scan will be performed and effective
      exposure doses will be between 1.5-1.8uSv which is comparable to 10 min on a transatlantic
      flight or one handful of Brazil nuts. The estimated total exposure dose for a single subject
      during the entire study is ~28uSv which is the same level of exposure as an average UK
      citizen is exposed to over the course of 4 days via background radiation.

      Results of the body composition, bone mineral density, jump height, muscular strength,
      aerobic fitness (maximal oxygen uptake: VO2max) and dietary intake from the self-reported
      food diaries will be made available to the subjects upon request. The results from the blood
      analysis will be reported to the subject if there are any health concerns raised. If the
      results are within healthy ranges the participants will not be contacted unless specifically
      requested for this information. The investigators will not be contacting their GPs if there
      are any concerns raised in the study however it will be stressed that participants should
      contact a GP to discuss the results found.

      Upon commencing the study, the participants will be required to track their incidence of
      illness and training habits during the 20-week experimental period between baseline and
      conclusion measurements. Throughout this period the incidence of illness and days trained
      during the months must be recorded in a check-list booklet, which will be provided. An email
      reminder will be sent to prompt all participants to complete these booklets on a daily basis
      during the experimental period, this should only take 1-2 minutes every evening. Throughout
      the duration of the trial, the participants will be contacted via telephone/ email on a
      monthly basis to discuss any issues and maintain good communication.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Seasonal Change in the Number of Participants with Deficiency in Vitamin D (according to government cut-off points in the UK and USA) in University Athletes and their Healthy Controls.
time frame: 1 year
description: This will be assessed by measuring serum 25(OH)D levels in participants during Autumn and Spring. Vitamin D status will be measured in nmol/L
measure: Seasonal Change in the Incidence of Injury in University Athletes
time frame: 1 year
description: Self reported questionnaire
measure: Seasonal Change in Bone Mineral Density in University Athletes
time frame: 1 year
description: mg/cm
measure: Seasonal Change in Bone Mineral Content in University Athletes
time frame: 1 year
description: mg/cm
measure: The change in vitamin D status due to participation in indoor or outdoor training in university level athletes between Autumn and Spring.
time frame: 1 year
description: hours and nmol/L
measure: Change between autumn and spring and the effects of high, medium and low impact sports on bone mineral density in university athletes
time frame: 1 year
description: mg/cm
measure: Changes from baseline in muscular power throughout an academic sporting season
time frame: 1 year
description: Vertical jump: cm
measure: Changes from baseline in muscular strength throughout an academic sporting season
time frame: 1 year
description: hand-grip strength: kg, knee extensor muscular strength: nM
measure: Changes from baseline in aerobic fitness throughout an academic sporting season
time frame: 1 year
description: ml/kg/min-1
measure: Change from baseline in the incidence of injury and illness and its correlation with vitamin D status
time frame: 1 year
description: Days of illness reported or missed training due to injury
arm group label: Male Athletes
description: DEXA, pQCT, lifestyle questionnaire, muscular strength measurements, aerobic fitness, blood draw and finger prick test.
arm group label: Female Athletes
description: DEXA, pQCT, lifestyle questionnaire, muscular strength measurements, aerobic fitness, blood draw and finger prick test.
arm group label: Controls
description: DEXA, pQCT, lifestyle questionnaire, muscular strength measurements, aerobic fitness, blood draw and finger prick test.
intervention type: Radiation
intervention name: DEXA
description: Dual energy X-ray absorptiometry (DEXA): a total of two scans will be performed, one for the assessment of whole body bone mineral density and body composition, and the other scan is performed to specifically assess fracture risk by scanning the hip and femoral head. Effective exposure doses for these scans are ~8uSv and ~4uSv respectively.
arm group label: Controls
arm group label: Female Athletes
arm group label: Male Athletes
other name: DXA
intervention type: Radiation
intervention name: pQCT
description: A total of one scan will be performed on the non-dominant Tibia, the effective exposure dose will be between 1.5-1.8uSV.
arm group label: Controls
arm group label: Female Athletes
arm group label: Male Athletes
intervention type: Other
intervention name: Lifestyle Questionnaire
description: Participants are required to record their lifestyle, diet (5-day self reported), physical activity (IPAQ questionnaire), injury and illness incidence.
arm group label: Controls
arm group label: Female Athletes
arm group label: Male Athletes
intervention type: Other
intervention name: Aerobic Fitness
description: Aerobic fitness will be tested using a VO2 max exercise protocol using a stationary cycle ergometer, the participants will be expected to perform this to maximal effort or exhaustion.
arm group label: Controls
arm group label: Female Athletes
arm group label: Male Athletes
intervention type: Other
intervention name: Muscular Strength
description: Muscular strength of the knee extensor and handgrip muscles will be determined using an Isokinetic Dynamometer and a handgrip dynamometer respectively.
arm group label: Controls
arm group label: Female Athletes
arm group label: Male Athletes
intervention type: Biological
intervention name: Blood draw and finger prick test
description: 15ml of whole blood will be collected for the measurement of fasting serum 25(OH)D levels, parathyroid hormone, C-terminal telopeptide (CTX) and full blood count
arm group label: Controls
arm group label: Female Athletes
arm group label: Male Athletes
intervention type: Other
intervention name: Muscular Power
description: Muscular power will be determined using an optical measurement system consisting of a transmitting and receiving bar to determine jump height through the interpretation of jump flight of the participant (reported in cm). The equipment used is an Optojump.
arm group label: Controls
arm group label: Female Athletes
arm group label: Male Athletes
Plasma and Serum samples obtained at baseline and visit 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan Lanham-New, Ph.D
role: Study Chair
affiliation: Head, Department of Nutritional Scienes
facility: 
facility: 
country: United Kingdom
citation: Halliday TM, Peterson NJ, Thomas JJ, Kleppinger K, Hollis BW, Larson-Meyer DE. Vitamin D status relative to diet, lifestyle, injury, and illness in college athletes. Med Sci Sports Exerc. 2011 Feb;43(2):335-43. doi: 10.1249/MSS.0b013e3181eb9d4d.
PMID: 20543748
citation: Close GL, Leckey J, Patterson M, Bradley W, Owens DJ, Fraser WD, Morton JP. The effects of vitamin D(3) supplementation on serum total 25[OH]D concentration and physical performance: a randomised dose-response study. Br J Sports Med. 2013 Jul;47(11):692-6. doi: 10.1136/bjsports-2012-091735. Epub 2013 Feb 14.
PMID: 23410885
citation: Farrokhyar F, Tabasinejad R, Dao D, Peterson D, Ayeni OR, Hadioonzadeh R, Bhandari M. Prevalence of vitamin D inadequacy in athletes: a systematic-review and meta-analysis. Sports Med. 2015 Mar;45(3):365-78. doi: 10.1007/s40279-014-0267-6.
PMID: 25277808
responsible party type: Principal Investigator
investigator affiliation: University of Surrey
investigator full name: Saskia Wilson-Barnes
investigator title: PhD Research Fellow
mesh term: Vitamin D Deficiency
sharing ipd: Undecided
provided document: 