<?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>IRCT2017081535716N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-22</date_registration>
      <primary_sponsor>-</primary_sponsor>
      <public_title>Changes of blood pressure and hemodynamic parameters after oral magnesium supplementation in patients with essential arterial hypertension</public_title>
      <acronym></acronym>
      <scientific_title>Changes of blood pressure and hemodynamic parameters after oral magnesium supplementation in patients with essential arterial hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26912</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: None.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Essential (primary) hypertension.</hc_freetext>
      <i_freetext>Daily oral supplementation with 300 mg of magnesium in the form of magnesium-oxide granules ("Magnezijum 300 Direkt" Hermes Arzneimittel GmbH, Germany) during one month at home. The granules were dissolved in the mouth with no liquid..</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>Nikolina Banjanin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr Subotica 8</address>
        <city>Belgrade</city>
        <country1>Serbia and Montenegro</country1>
        <zip></zip>
        <telephone>00381113612762</telephone>
        <email>nikolina.banjanin@med.bg.ac.rs</email>
        <affiliation>Institute of Hygiene and Medical Ecology, Faculty of Medicine, University of Belgrade</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nikolina Banjanin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr Subotica 8</address>
        <city>Belgrade</city>
        <country1>Serbia and Montenegro</country1>
        <zip></zip>
        <telephone>00 381 11 3612762</telephone>
        <email>nikolina.banjanin@med.bg.ac.rs</email>
        <affiliation>Institute of Hygiene and Medical Ecology, Faculty of Medicine, University of Belgrade</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Serbia and Montenegro</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:age 24-65; essential arterial hypertention; unchanged antihipertensive therapy for at least one month; &#13;
Exclusion criteria: renal diseases, gastrointestinal diseases, diabetes mellitus, diseases od adrenal, thyroid and parathyroid glands, angina pectoris, congestive heart failure, aortic coarctation, food and drugs allergy, pregnancy, lactation, myocardial infarction, coronary revascularisation, transitory ischemic attack, oral intake of magnesium supplements in the last one month</inclusion_criteria>
      <agemin>24 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>High blood pressure, Hypertension (arterial)(benign)(essential)(malignant)(primary)(systemic)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Daily oral supplementation with 300 mg of magnesium in the form of magnesium-oxide granules ("Magnezijum 300 Direkt" Hermes Arzneimittel GmbH, Germany) during one month at home. The granules were dissolved in the mouth with no liquid.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure (mm Hg). Timepoint: Before and after intervention. Method of measurement: Sphygmomanometer and Impedance cardiography.</prim_outcome>
      <prim_outcome>Heart rate (beats per minute). Timepoint: Before and after intervention. Method of measurement: Impedance cardiography.</prim_outcome>
      <prim_outcome>Thoracic fluid content (L/kOhm). Timepoint: Before and after intervention. Method of measurement: Impedance cardiography.</prim_outcome>
      <prim_outcome>Stroke Volume (mL). Timepoint: Before and after intervention. Method of measurement: Impedance cardiography.</prim_outcome>
      <prim_outcome>Stroke index (mL/m2). Timepoint: Before and after intervention. Method of measurement: Impedance cardiography.</prim_outcome>
      <prim_outcome>Cardiac output (L/min). Timepoint: Before and after intervention. Method of measurement: Impedance cardiography.</prim_outcome>
      <prim_outcome>Cardiac index (L/(min*m2). Timepoint: Before and after intervention. Method of measurement: Impedance cardiography.</prim_outcome>
      <prim_outcome>Acceleration index (L/100/s2). Timepoint: Before and after intervention. Method of measurement: Impedance cardiography.</prim_outcome>
      <prim_outcome>Left cardiac work index (kg*m/m²). Timepoint: Before and after intervention. Method of measurement: Impedance cardiography.</prim_outcome>
      <prim_outcome>Systemic vascular resistance index (dyn*s*m2/cm5). Timepoint: Before and after intervention. Method of measurement: Impedance cardiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>-</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-01</approval_date>
        <contact_name>Ethics Committee of the Faculty of Medicine, University of Belgrade</contact_name>
        <contact_address>Dr Subotica 8 Belgrade Serbia Serbia and Montenegro</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-09-16</approval_date>
        <contact_name>Ethics Committee of the Clinical Center Of Serbia</contact_name>
        <contact_address>Pasterova 2 Belgrade Serbia Serbia and Montenegro</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
