<?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>IRCT20231109060002N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-23</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of vitamin D supplementation on schizophrenia symptoms</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of vitamin D supplementation on schizophrenia symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73674</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants are randomly divided into each intervention and control group by simple random method using the RAND function of Excel software, Blinding description: The method of blinding the participants, researchers and the statistical analyzer of the plan to the intervention pills is that for this purpose, the manufacturer packs the capsules in similar packages and identifies them with the names A and B. Until after the researchers study, the participants and the statistical analyzer do not know about their nature, and a trusted expert will know about the main nature of the supplement and placebo until the end of the project.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: According to previous studies, the dose of vitamin D supplement is 50,000 IU weekly for 12 weeks, and after 12 weeks (three months from the start of taking the supplement), the supplement is taken once a month. It is consumed until the end of the 24th week (6 months from the start of taking the supplement). At the beginning of the study and at the end of the 12th week and at the end of the 24th week, the level of vitamin D and the score of the psychological tests are evaluated. Intervention 2: Control group: Placebo (sunflower oil) with the same packaging as a 50,000 IU dose supplement is considered weekly. It is considered weekly for a period of 12 weeks, and after 12 weeks (three months from the start of taking the placebo), the placebo is taken once a month until the end of the 24th week (6 months from the start of taking the placebo). At the beginning of the study, at the end of the 12th week and at the end of the 24th week, the level of vitamin D and the score of the psychological tests are evaluated.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Malihe Samsami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd Specialized Psychiatric Hospital., First of  Shahid Beheshti Blv.,Taft., YAZD</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8991683111</zip>
        <telephone>+98 35 3263 2003</telephone>
        <email>samsami.psy@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvane Rashidpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd, Taft, at the beginning of Shahid Beheshti Blvd., Specialized Psychiatric Hospital of Yazd Province</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8991683111</zip>
        <telephone>+98 35 3263 2003</telephone>
        <email>parvanerashidpour@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of chronic outpatient schizophrenia (at least three years have passed since the onset of the disease and at least one year under treatment with antipsychotic drugs) based on DSM5 by a psychiatrist
Vitamin D level below 30ng
under treatment for at least 8 weeks with a fixed dose of the drug
score question (PANSS) above 70</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Received ECT in the past two months
Mental retardation
Organic brain disease and history of head trauma
History of drug and alcohol use
Non-cooperation in filling out the questionnaire
Non-cooperation in taking medicine or changing its dosage​
Non-cooperation in taking vitamin D supplements
Kidney, heart, thyroid disorders and diseases, hemorrhagic diseases and malignancies
Pregnancy and breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: According to previous studies, the dose of vitamin D supplement is 50,000 IU weekly for 12 weeks, and after 12 weeks (three months from the start of taking the supplement), the supplement is taken once a month. It is consumed until the end of the 24th week (6 months from the start of taking the supplement). At the beginning of the study and at the end of the 12th week and at the end of the 24th week, the level of vitamin D and the score of the psychological tests are evaluated.</i_keyword>
      <i_keyword>Control group: Placebo (sunflower oil) with the same packaging as a 50,000 IU dose supplement is considered weekly. It is considered weekly for a period of 12 weeks, and after 12 weeks (three months from the start of taking the placebo), the placebo is taken once a month until the end of the 24th week (6 months from the start of taking the placebo). At the beginning of the study, at the end of the 12th week and at the end of the 24th week, the level of vitamin D and the score of the psychological tests are evaluated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Montreal Mocha cognitive test MoCA. Timepoint: The beginning of the study, the end of week 12, the end of week 24. Method of measurement: Moka cognitive assessment questionnaire is measured and implemented for all participants by a clinical psychologist.​.</prim_outcome>
      <prim_outcome>PANSS positive and negative symptom evaluation test. Timepoint: The beginning of the study, the end of week 12, the end of week 24. Method of measurement: The questionnaire for evaluating positive and negative symptoms of schizophrenia is measured and implemented by a clinical psychologist for all participants.</prim_outcome>
      <prim_outcome>Vitamin D serum level. Timepoint: The beginning of the study, the end of week 12, the end of week 24. Method of measurement: In order to perform laboratory tests before and after the intervention, 10 cc of venous blood will be collected, its serum will be separated and removed. All tests are performed in a single laboratory in a public hospital. Prescribing the test and interpretation of the results will be done by the psychiatrist of Yazd Psychiatric Hospital.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-08</approval_date>
        <contact_name>Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Vice President of Research and Technology, Shahid Sadoughi University of Medical Sciences., First of Imam Reza Educational Research Building., Student Bld., Imam Hossein Sq., YAZD Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
