<?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>IRCT20180921041080N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-30</date_registration>
      <primary_sponsor>Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of L-carnitine in the treatment of anemia</public_title>
      <acronym></acronym>
      <scientific_title>L-carnitine effects on anemia improvement in patients undergoing hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34002</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation method was used to assign participants in blocks of four. There are six probabilities for block size of four (six cards). A hundred participants were assigned randomly using the cards twenty-five times. 
AABB
ABAB
BBAA
BAAB
ABBA
BABA
The first choice was done using simple randomizing method and table of random numbers. Having selected the first card, other participants are selected according to the rounds. Cards labelled (A) referred to intervention group, and cards labelled (B) referred to control group. Therefore, fifty participants are assigned in each group (intervention and control). Sampling will continue until all the participants are assigned in the groups randomly, Blinding description: Patients in both the intervention and control groups and the nurses who provide the drug and the drug to the patients will not be aware of the type of drug. The placebo was similar to the drug in terms of shape, color, size, weight and packaging.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic renal Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group will treated for 12 weeks with a single daily dose of L-carnitine tablets containing one gram of L-carnitine tartrate produced by the Karen Pharmaceutical Company. The tablet will be taken with a glass of water after meals. Intervention 2: Control group: The patients of the control group were treated by placebo, which resembles L.Carnitine tablets with a dose of 1 gram completely, made by Karen Pharmaceutical Company one daily after meal for 12 weeks.</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:
Regarding the fact that the present study has been registered as a research project in the “Research Management System of Medical Sciences University of Kurdistan”, it is required to present and register the final report in the “National Health Research Results Database”. Therefore, the sharing process of this study will be done step by step accordingly. It is essential to mention than the results of this study will be published in terms of statistical data, tables and figures in the extracted paper.

When:
One year

To whom:
Everyone

Conditions:
After publishing article

Where to obtain:
Regarding the fact that presenting and registering the results of the study in a profile on “National Health Research Database” of Medical Sciences University of Kurdistan, and publishing the final paper and registering the researchers’ information in the mentioned database, it will be possible to contact the researchers through emailing and deputy of research and technology of the university.

How to obtain:
The researchers will be willing to respond emails requesting information, which is not considered confidential and private, about the patients being studied. This is also possible through contacting deputy of research and technology of the university.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Anvar Mohamadi Baneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Avn.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1344666177</zip>
        <telephone>+98 87 3328 7100</telephone>
        <email>dr.khorshidy@gmail.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Anvar Mohamadi Baneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Avn.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1344666177</zip>
        <telephone>+98 87 3328 7100</telephone>
        <email>dr.khorshidy@gmail.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing hemodialysis
Having anemia
Hemodialysis more than one year
Age more than 20 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>74 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having infectious, hepatic, and cancer diseases
Previous use of L-carnitine supplement
Use of corticosteroids
Narcotic drugs, alcohol, and cigarette consumption</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</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 group: Patients in the intervention group will treated for 12 weeks with a single daily dose of L-carnitine tablets containing one gram of L-carnitine tartrate produced by the Karen Pharmaceutical Company. The tablet will be taken with a glass of water after meals.</i_keyword>
      <i_keyword>Control group: The patients of the control group were treated by placebo, which resembles L.Carnitine tablets with a dose of 1 gram completely, made by Karen Pharmaceutical Company one daily after meal for 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anemia. Timepoint: Mean serum hemoglobin, ferritin and iron levels are measured at the beginning and three months after the start of treatment. Method of measurement: Blood sampling.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Kurdistan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-21</approval_date>
        <contact_name>ٍEthics committee of Kurdistan University of Medical Sciencess</contact_name>
        <contact_address>Pasdaran Ave Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
