<?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>IRCT20131117015424N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-07</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of vitamin D on athletes</public_title>
      <acronym></acronym>
      <scientific_title>Effects of vitamin D supplementation on serum levels of adipose tissue browning endocrine regulators, anabolic hormone and exercise performance in male athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30147</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will randomly assigned into two groups receiving either vitamin D supplements or a placebo group,with using random number table, Blinding description: In the present study, participants and researcher will be blinded to the studying groups. Prior to the study, the cans containing the respective pills will be coded by a person other than the researcher to A and B so that the type of received pills in each group will be blinded for researcher.</study_design>
      <phase>3</phase>
      <hc_freetext>Athletes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Daily intake of vitamin D supplement with a dose of 2000 international unit of Zahrawi company (Iran) for 12 weeks. Intervention 2: Control group: Daily intake of a placebo that look likes vitamin D supplement and contains maltodextrin.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data related to outcomes of the study will be published in the article as a comparison between groups.

When:
Data will be available 6 months after publication.

To whom:
Access to this information will be allowed for researchers and people involved in their work with athletes (such as sports coaches or professional athletes).

Conditions:
Data will not be available for analysis to other people, but the study protocol, the method of analysis and the final results will be presented so that people are aware of the correctness of the method of study.

Where to obtain:
You can refer to the Department of Nutrition Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, or email shahi334@gmail.com to receive the documentation.

How to obtain:
If the applicant's request is announced in accordance with the terms, it can be sent to the person within one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Mohamadshahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Science, Golestan Ave, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 912 439 2836</telephone>
        <email>mohamadshahi-m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Mohamadshahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Science, Golestan Ave, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 912 439 2836</telephone>
        <email>mohamadshahi-m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Intention to participate
BMI between 18.5 to 29.9
Vo2max between 40-60 ml/kg/min
Regular physical activity for at least three times per week each time</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>No intention to participate
Presence of metabolic diseases
Presence of diagnosed renal (acute or chronic) and bone disease
Smoking
Using other supplements at the beginning of the study or during past 3 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Daily intake of vitamin D supplement with a dose of 2000 international unit of Zahrawi company (Iran) for 12 weeks</i_keyword>
      <i_keyword>Control group: Daily intake of a placebo that look likes vitamin D supplement and contains maltodextrin</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum levels of Fibroblast Growth Factor-21. Timepoint: pre-intervention and after 12 weeks of intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) kit.</prim_outcome>
      <prim_outcome>Serum levels of Bone morphogenetic protein 4. Timepoint: pre-intervention and after 12 weeks of intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) kit.</prim_outcome>
      <prim_outcome>Serum levels of meteorin-like. Timepoint: pre-intervention and after 12 weeks of intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) kit.</prim_outcome>
      <prim_outcome>Serum levels of interleukin-15. Timepoint: pre-intervention and after 12 weeks of intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) kit.</prim_outcome>
      <prim_outcome>Serum levels of Growth hormone. Timepoint: pre-intervention and after 12 weeks of intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) kit.</prim_outcome>
      <prim_outcome>Serum levels of Insulin-like growth factor 1. Timepoint: pre-intervention and after 12 weeks of intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) kit.</prim_outcome>
      <prim_outcome>Serum levels of testosterone. Timepoint: pre-intervention and after 12 weeks of intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) kit.</prim_outcome>
      <prim_outcome>Aerobic performance. Timepoint: pre-intervention and after 12 weeks of intervention. Method of measurement: By estimating the maximal oxygen uptake (Vo2 max) using the Bruce test.</prim_outcome>
      <prim_outcome>Anaerobic performance. Timepoint: pre-intervention and after 12 weeks of intervention. Method of measurement: Be determined on the basis of 30-second Wingate test using a Monark bike.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum levels of cortisol. Timepoint: pre-intervention and after 12 weeks of  intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) kit.</sec_outcome>
      <sec_outcome>Serum levels of Parathyroid hormone. Timepoint: pre-intervention and after 12 weeks of  intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) kit.</sec_outcome>
      <sec_outcome>Serum levels of 25-hydroxy vitamin D. Timepoint: pre-intervention and after 12 weeks of  intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) kit.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-21</approval_date>
        <contact_name>Ethics committee of Ahvaz Jondishapour University of Medical Science</contact_name>
        <contact_address>Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
