<?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>IRCT20211026052878N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-18</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of vitamin D on recurrence of chronic rhinosinusitis associated with nasal polyposis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of vitamin D on recurrence of chronic rhinosinusitis associated with nasal polyposis after functional endoscopic sinus surgery (Triple blind, Placebo-controlled randomized clinical trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59878</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Blocked Randomization is used. Four blocks of defined intervention (A) and control (B) groups (AABB, ABAB, ABBA, BBAA, BABA, BAAB) and written on cards 1-6, the cards are placed in the envelope. The cards are then randomly selected and a random string is made from the selected card sequence. Patients in the intervention and control groups are included in the study based on this sequence, Blinding description: Participants,  the surgeon, the statistician who analyzes the study are kept blind to their assignment to study groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic rhinosinusitis with nasal polyposis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients with chronic rhinosinusitis associated with polyposis treated with vitamin D. Both control and intervention groups will be divided into three subgroups. The first subgroup has a vitamin D level below 20 ng / ml (deficient), the second subgroup has a vitamin D level of 20-29 ng / ml (Insufficient), the third subgroup has a vitamin D level greater than 30 ng / ml (Sufficient).The first subgroup receives 50,000 units of vitamin D eight weeks weekly and then  monthly. The second subgroup receives 50,000 units of vitamin D eight weeks weekly and then monthly. The third subgroup receives 50,000 units of vitamin D per month. Intervention 2: Control group: Patients with chronic rhinosinusitis associated with polyposis treated with placebo in a similar way.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leyla Noury</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Saadi Street, the new building of Amir Alam Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1145755811</zip>
        <telephone>+98 21 6670 6106</telephone>
        <email>leyla.noury@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leyla Noury</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Saadi Street, the new building of Amir Alam Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1145755811</zip>
        <telephone>+98 21 6670 6106</telephone>
        <email>leyla.noury@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients referred to Amiralam Hospital with chronic nasal sinusitis with polyposis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction
Getting Covid 19 and getting vitamin D followed while studying
Patients with acute complications of chronic sinusitis
Taking immunosuppressive drugs
Contraceptive drug use (OCP)
Taking Anti TB drugs
Patients with active infection
Recent hypercalcemia or history of hypercalcemia
Get anticonvulsant medicine
Nephrolithiasis
Recent tanning history
Pregnancy
Breastfeeding
History of malabsorption
Vitamin D levels above 80
Continuous vitamin D3 supplementation over 400 units per day
Acute exacerbation of acute bacterial sinusitis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J32.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic sinusitis, unspecified</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 with chronic rhinosinusitis associated with polyposis treated with vitamin D. Both control and intervention groups will be divided into three subgroups. The first subgroup has a vitamin D level below 20 ng / ml (deficient), the second subgroup has a vitamin D level of 20-29 ng / ml (Insufficient), the third subgroup has a vitamin D level greater than 30 ng / ml (Sufficient).The first subgroup receives 50,000 units of vitamin D eight weeks weekly and then  monthly. The second subgroup receives 50,000 units of vitamin D eight weeks weekly and then monthly. The third subgroup receives 50,000 units of vitamin D per month.</i_keyword>
      <i_keyword>Control group: Patients with chronic rhinosinusitis associated with polyposis treated with placebo in a similar way.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient score in SNOT-22 questionnaire. Timepoint: One month, three months and six months after surgery. Method of measurement: The Sino-Nasal Outcome Test (SNOT-22).</prim_outcome>
      <prim_outcome>Patient score in Lund-Mackay score of CT scan. Timepoint: One month, three months and six months after surgery. Method of measurement: Lund-Mackay score of CT scan.</prim_outcome>
      <prim_outcome>Patient score in Lund-Kennedy score. Timepoint: One month, three months and six months after surgery. Method of measurement: Lund-Kennedy score.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-17</approval_date>
        <contact_name>Ethics committee Tehran of University of Medical Sciences</contact_name>
        <contact_address>Keshavarz Blvd., Ghods St., Vice Chancellor for Research and Technology, Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
