<?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>IRCT2013121515807N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-03-07</date_registration>
      <primary_sponsor>Research Deputy of Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of sports supplements L- Arginine on athletic performance</public_title>
      <acronym></acronym>
      <scientific_title>Effect of supplementation of L- arginine on exercise performance, body composition,Hematological indices in 35-18 year old male athletes with cardiovascular disease prevention approach</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14967</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Randomization include: L - arginine and placebo is Randomly coded by someone outside the research team  and the research team know the type of supplement. The statistical analysis is unaware of the type of intervention and after the end of the project and the final report will determine the type of intervention.</study_design>
      <phase>2</phase>
      <hc_freetext>Prevention of cardiovascular disease risk and improve exercise performance in healthy subjects.</hc_freetext>
      <i_freetext>Intervention 1: Intervention with l- arginine supplementation (2 g per day) in 45 days in the intervention group. L-arginine pills is 1 gram &amp; athletes take 2 tablets daily. Intervention 2: Placebo (2 g per day) in 45 days in the control group. Malto dextrin pills is 1 gram &amp; athletes take 2 tablets daily.</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>Naseh Pahlavani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition &amp; Food Science, Isfahan University of Medical Science, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 937 608 1205</telephone>
        <email>Nasehp67@gmail.com</email>
        <affiliation>Student</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mohammad Hasan Entezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Food Science, Isfahan University of Medical Sciences, Hezarjarib St, Isfahan  Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1792 2776</telephone>
        <email>Entezari@hlth.mui.ac.ir</email>
        <affiliation>Isfahan University f Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria included: 18-35 years old males; willing to participate in study; no smoking and alcohol; history of continuous exercise at least twice a week in a years ago; no consumption dietary supplement in the last two months; lack of history of acute or chronic disease.  Exclusion criteria: failure to follow of intervention; consumption of any dietary supplements in duration of study; catching acute or chronic disease during intervention.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z00.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other general examinations</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention with l- arginine supplementation (2 g per day) in 45 days in the intervention group. L-arginine pills is 1 gram &amp; athletes take 2 tablets daily.</i_keyword>
      <i_keyword>Placebo (2 g per day) in 45 days in the control group. Malto dextrin pills is 1 gram &amp; athletes take 2 tablets daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Performance. Timepoint: Before&amp; after 45 intervention. Method of measurement: Harvard Step Test.</prim_outcome>
      <prim_outcome>Sodium, potassium, fasting blood glucose and lipid profile. Timepoint: Before&amp; after 45 intervention. Method of measurement: Blood tests.</prim_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Before&amp; after 45 intervention. Method of measurement: Mercurial pressure gauge.</prim_outcome>
      <prim_outcome>Body composition. Timepoint: Before&amp; after 45 intervention. Method of measurement: Body composition analyser.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Isfahan University of Medical Science</sponsor_name>
      <sponsor_name>Assistance Reaserch of Isfahan University of Medical Science</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Research Deputy of Isfahan University of Medical Sciences</source_name>
      <source_name>Isfahan University of Medical Science</source_name>
      <source_name>Assistance Reaserch of Isfahan University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-10-23</approval_date>
        <contact_name>Isfahan Regional Bioethics Committee</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezarjarib St., Isfahan, Iran Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-08-20</approval_date>
        <contact_name>Isfahan University of Medical Science</contact_name>
        <contact_address>Iran, Isfahan, hezarjerib Ave, Isfahan University of Medical Science,Faculty of Nutrition and Food Science Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
