<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2017042613678N27</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-26</date_registration>
      <primary_sponsor>Vice Chancellor for research of Urmia university of medical sciences</primary_sponsor>
      <public_title>Effect of vitamin D on inflammation and muscle damage in athletes</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of Cholecalciferol supplementation on inflammatory markers and muscle damage indices in soccer players after a simulated soccer match</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13468</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization method was Balanced block.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: inflammation. Condition 2: muscle damage.</hc_freetext>
      <i_freetext>Intervention 1: Experimental group will receive supplement for 8 weeks (each week they should eat one 50000 IU cholecalciferol pearl). &#13;
After 8 weeks, players will participate in a simulated soccer match at the test day. The protocol of the simulated soccer match is according to Loughbrough intermittent shuttle run test. The test comprised two parts, Part A and Part B.&#13;
Part A was of a fixed duration and consisted of five 15&#13;
min exercise periods separated by 3 min of recovery. The exercise periods consisted of a set pattern&#13;
of intermittent high-intensity running,&#13;
and were designed to be similar to the activity pattern&#13;
typically recorded for soccer match play.&#13;
The pattern of exercise for Part A was as follows:&#13;
 3 ´ 20 m at walking pace; 1 ´ 20 m at maximal running speed; 4 s recovery;  3 ´ 20 m at a running speed corresponding to 55% of individual VO2max;  3 ´ 20 m at a running speed corresponding to 95% of individual VO2max&#13;
This pattern of exercise was repeated for each 15 min&#13;
block followed by a rest period of 3 min. Altogether, five15&#13;
min exercise blocks were completed, separated by 3 min&#13;
of recovery, before the start of Part B.&#13;
Part B was an open-ended period of intermittent&#13;
shuttle running, designed to exhaust the participants&#13;
within approximately 15 min. The participants were&#13;
required to run at speeds corresponding to 55% and&#13;
95% of predicted VO2max , the speed alternating every 20 m. This pattern of exercise was repeated continuously&#13;
until the participants were unable to maintain the&#13;
required speed for two consecutive shuttles at the higher&#13;
of the two exercise intensities. Intervention 2: Control group will receive placebo for 8 weeks (each week they should eat one oral paraffin pearl). After 8 weeks, players will participate in a simulated soccer match at the test day. The protocol of the simulated soccer match is according to Loughbrough intermittent shuttle run test. The test comprised two parts, Part A and Part B.&#13;
Part A was of a fixed duration and consisted of five 15&#13;
min exercise periods separated by 3 min of recovery. The exercise periods consisted of a set pattern&#13;
of intermittent high-intensity running,&#13;
and were designed to be similar to the activity pattern&#13;
typically recorded for soccer match play.&#13;
The pattern of exercise for Part A was as follows:&#13;
 3 ´ 20 m at walking pace; 1 ´ 20 m at maximal running speed; 4 s recovery;  3 ´ 20 m at a running speed corresponding to 55% of individual VO2max;  3 ´ 20 m at a running speed corresponding to 95% of individual VO2max&#13;
This pattern of exercise was repeated for each 15 min&#13;
block followed by a rest period of 3 min. Altogether, five15&#13;
min exercise blocks were completed, separated by 3 min&#13;
of recovery, before the start of Part B.&#13;
Part B was an open-ended period of intermittent&#13;
shuttle running, designed to exhaust the participants&#13;
within approximately 15 min. The participants were&#13;
required to run at speeds corresponding to 55% and&#13;
95% of predicted VO2max , the speed alternating every 20 m. This pattern of exercise was repeated continuously&#13;
until the participants were unable to maintain the&#13;
required speed for two consecutive shuttles at the higher&#13;
of the two exercise intensities.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Ghavamzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medicine college, Urmia university of medical sciences, Nazloo road</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 440000000</telephone>
        <email>ghavamzadeh@hotmail.com</email>
        <affiliation>Urmia university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Saied Ghavamzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department, Faculty of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 44 3278 0803</telephone>
        <email>ghavamzadeh_s@yahoo.com; ghavamzadeh@hotmail.com</email>
        <affiliation>Urmia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: soccer players who want to collaboration; players who regularly and consistently participate in soccer practices and matches(at least 4 month passed from starting this sport); age group between 18 to 30 years old; healthy players without any injury, cardio-metabolic disease, orthopedic and inflammatory disease; players without any acute liver disease, biliary, kidney and digestive  disease; players with no history of kidney stone and hyperparathyroidism and osteomalasia or osteoporosis and sarcoidosis; lack of vitamin D supplementation at least for 8 weeks before the study beginning; lack of using drugs which can affect vitamin D level and its metabolism and function such as steroid and anti-epileptic drugs; lack of using certain drugs such as acetaminophen and anti-inflammatory drugs and b blockers and statins; lack of using exogenous hormones; lack of using amphotericin B,ampicilin, anticoagulant drugs, aspirin, clofibrate, cocaine, lithium, furosemide, morphine and some of anesthetic drugs; lack of using epinephrine and sodium bicarbonate; lack of using orlistate and cholestyramine and other cholesterol reducing drugs; people by BMI group 18.5 to 30; lack of smoking and alcohol consumption; people with 25(oh)D serum concentration less than 40 ng/mL.&#13;
exclusion criteria: lack of collaboration for continuing the study; using certain drugs during the study; using foods rich in vitamin D specially canned fish, cod fish oil, Salmon and vit D fortified foods; using less than 80 % of supplements; traveling to place with sunny weather during the study; injury or disease occurrence during the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>-</hc_code>
      <hc_code>-</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>-</hc_keyword>
      <hc_keyword>-</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental group will receive supplement for 8 weeks (each week they should eat one 50000 IU cholecalciferol pearl). &#13;
After 8 weeks, players will participate in a simulated soccer match at the test day. The protocol of the simulated soccer match is according to Loughbrough intermittent shuttle run test. The test comprised two parts, Part A and Part B.&#13;
Part A was of a fixed duration and consisted of five 15&#13;
min exercise periods separated by 3 min of recovery. The exercise periods consisted of a set pattern&#13;
of intermittent high-intensity running,&#13;
and were designed to be similar to the activity pattern&#13;
typically recorded for soccer match play.&#13;
The pattern of exercise for Part A was as follows:&#13;
 3 ´ 20 m at walking pace; 1 ´ 20 m at maximal running speed; 4 s recovery;  3 ´ 20 m at a running speed corresponding to 55% of individual VO2max;  3 ´ 20 m at a running speed corresponding to 95% of individual VO2max&#13;
This pattern of exercise was repeated for each 15 min&#13;
block followed by a rest period of 3 min. Altogether, five15&#13;
min exercise blocks were completed, separated by 3 min&#13;
of recovery, before the start of Part B.&#13;
Part B was an open-ended period of intermittent&#13;
shuttle running, designed to exhaust the participants&#13;
within approximately 15 min. The participants were&#13;
required to run at speeds corresponding to 55% and&#13;
95% of predicted VO2max , the speed alternating every 20 m. This pattern of exercise was repeated continuously&#13;
until the participants were unable to maintain the&#13;
required speed for two consecutive shuttles at the higher&#13;
of the two exercise intensities.</i_keyword>
      <i_keyword>Control group will receive placebo for 8 weeks (each week they should eat one oral paraffin pearl). After 8 weeks, players will participate in a simulated soccer match at the test day. The protocol of the simulated soccer match is according to Loughbrough intermittent shuttle run test. The test comprised two parts, Part A and Part B.&#13;
Part A was of a fixed duration and consisted of five 15&#13;
min exercise periods separated by 3 min of recovery. The exercise periods consisted of a set pattern&#13;
of intermittent high-intensity running,&#13;
and were designed to be similar to the activity pattern&#13;
typically recorded for soccer match play.&#13;
The pattern of exercise for Part A was as follows:&#13;
 3 ´ 20 m at walking pace; 1 ´ 20 m at maximal running speed; 4 s recovery;  3 ´ 20 m at a running speed corresponding to 55% of individual VO2max;  3 ´ 20 m at a running speed corresponding to 95% of individual VO2max&#13;
This pattern of exercise was repeated for each 15 min&#13;
block followed by a rest period of 3 min. Altogether, five15&#13;
min exercise blocks were completed, separated by 3 min&#13;
of recovery, before the start of Part B.&#13;
Part B was an open-ended period of intermittent&#13;
shuttle running, designed to exhaust the participants&#13;
within approximately 15 min. The participants were&#13;
required to run at speeds corresponding to 55% and&#13;
95% of predicted VO2max , the speed alternating every 20 m. This pattern of exercise was repeated continuously&#13;
until the participants were unable to maintain the&#13;
required speed for two consecutive shuttles at the higher&#13;
of the two exercise intensities.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Interleukin 6. Timepoint: at the end of the trial: before the simulated test, immediately after the test, 2 and 24 hours after the test. Method of measurement: lab test.</prim_outcome>
      <prim_outcome>CRP. Timepoint: at the end of the trial: before the simulated test, immediately after the test, 2 and 24 hours after the test. Method of measurement: lab test.</prim_outcome>
      <prim_outcome>Lactate dehydrogenase. Timepoint: at the end of the trial: before the simulated test, immediately after the test, 2 and 24 hours after the test. Method of measurement: lab test.</prim_outcome>
      <prim_outcome>Creatine phosphate kinase. Timepoint: at the end of the trial: before the simulated test, immediately after the test, 2 and 24 hours after the test. Method of measurement: lab test.</prim_outcome>
      <prim_outcome>Serum 25-oh vitamin D3 level. Timepoint: before and after the trial: immidiately before the soccer simulated test. Method of measurement: lab test.</prim_outcome>
      <prim_outcome>Body composition. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Body composition analyzer (BIA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Rating of Perceived Exertion. Timepoint: immidiately after each partof the simulated test. Method of measurement: questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>-</sec_id>
        <issuing_authority>-</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor for research of Urmia university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-26</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>urmia, staff of urmia university of medical sciences urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
