<?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>IRCT201601045623N65</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-04</date_registration>
      <primary_sponsor>Vice chancellor for research, Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of supplementation in treatment of women with cervical intraepithelial neoplasia 2 and 3</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of the effect of vitamin D supplementation compared with the placebo on recurrence and metabolic profiles in women with cervical intraepithelial neoplasia 2 and 3</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6095</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Oncology Clinic at the Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules, Randomization description: t study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D supplements (n = 29) or placebo (n = 29). Randomization will be done by the use of computer-generated random numbers, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Oncology Clinic at the Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.</study_design>
      <phase>3</phase>
      <hc_freetext>Cervical intraepithelial neoplasia 2 and 3.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Vitamin D supplement, 50000 IU, every 2 weeks, for 6 months orally. Intervention 2: Control group: Placebo, every 2 weeks,  for 6 months orally.</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 Undecided - It is not yet known if there will be a plan to make this available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zatollah Asemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bolvare Ghotbe Ravandi, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8115187159</zip>
        <telephone>+98 31 5546 3378</telephone>
        <email>asemi_r@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zatollah Asemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghotbe Ravandi Boulevard, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8115187159</zip>
        <telephone>+98 31 5546 3378</telephone>
        <email>asemi_r@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with cervical intraepithelial neoplasia 2 and 3
Aged 25 to 65 years old</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women who had a history of cervical cancer or other cancers of the lower genital tract
History of hysterectomy or destructive therapy of the cervix
Pregnant women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C53.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cervix uteri, 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: Vitamin D supplement, 50000 IU, every 2 weeks, for 6 months orally.</i_keyword>
      <i_keyword>Control group: Placebo, every 2 weeks,  for 6 months orally.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Recurrence. Timepoint: Six months after intervention. Method of measurement: Colposcopy.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insulin. Timepoint: At the beginning of the study and after 6 months of intervention. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Nitric oxide. Timepoint: At the beginning of the study and after 6 months of intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Hs-CRP. Timepoint: At the beginning of the study and after 6 months of intervention. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Triglycerides. Timepoint: At the beginning of the study and after 6 months of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Cholesterol. Timepoint: At the beginning of the study and after 6 months of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Total antioxidant. Timepoint: At the beginning of the study and after 6 months of intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Malondialdehyde. Timepoint: At the beginning of the study and after 6 months of intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: At the beginning of the study and after 6 months of intervention. Method of measurement: Baseline and End-of-trial.</sec_outcome>
      <sec_outcome>Serum vitamin D. Timepoint: At the beginning of the study and after 6 months of intervention. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>HDL. Timepoint: At the beginning of the study and after 6 months of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Insulin resistance. Timepoint: At the beginning of the study and after 6 months of intervention. Method of measurement: Calculation using HOMA formula.</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>Vice chancellor for research, Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-22</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
