<?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>IRCT201305115623N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-23</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of vitamin D in treatment of gestational diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Effect of vitamin D supplementation on insulin resistance and inflammatory factors in women with gestational diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-05-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6037</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease potential confounding effects, all participants will have stratified randomization according to BMI and weeks of gestation. Then, participants in each block will be randomly allocated into two treatment groups to take either vitamin D supplement or placebo. Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups. https://stattrek.com/statistics/random-number-generator.aspx, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the maternity clinics affiliated with 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. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.</study_design>
      <phase>2</phase>
      <hc_freetext>Gestational diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Vitamin D3 capsule ( Zahravi Pharm Co, Iran), 50000 IU, every 3 weeks for 6 weeks orally. Intervention 2: Control group: Placebo capsule (Barij Essence Co, Iran), every 3 weeks for 6 weeks 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>Ghotbe Ravandi Boulevard, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81151-87159</zip>
        <telephone>+98 31 5562 0608</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>Bolvare Ghotbe Ravandi, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81151-87159</zip>
        <telephone>+98 36 1446 3378</telephone>
        <email>asemi_z@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women aged 18-40 years
Women diagnosed with Gestational Diabetes Mellitus
24-28 weeks' gestation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Premature preterm rupture of membrane
Placenta abruption
Preeclampsia
Those who required commencing insulin therapy during intervention
Those with hypothyroidism
Urinary tract infection
Smoking
Those with kidney or liver diseases
Those taking estrogen therapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus in pregnancy, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Vitamin D3 capsule ( Zahravi Pharm Co, Iran), 50000 IU, every 3 weeks for 6 weeks orally.</i_keyword>
      <i_keyword>Control group: Placebo capsule (Barij Essence Co, Iran), every 3 weeks for 6 weeks orally.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>25-hydroxyvitamin D. Timepoint: Baseline and End-of-trial. Method of measurement: ELISA kit.</prim_outcome>
      <prim_outcome>Newborn's lengt. Timepoint: Delivery time. Method of measurement: Tape.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total antioxidant capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Glutathione. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>High-sensitivity C-reactive protein. Timepoint: Baseline and End-of-trial. Method of measurement: ELISA kit.</sec_outcome>
      <sec_outcome>Insulin. Timepoint: Baseline and End-of-trial. Method of measurement: ELISA kit.</sec_outcome>
      <sec_outcome>Insulin resistance. Timepoint: Baseline and End-of-trial. Method of measurement: Calculation using HOMA formula.</sec_outcome>
      <sec_outcome>Triglycerides. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Total cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>HDL. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Fasting plasma glucose. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Ponderal index. Timepoint: Delivery time. Method of measurement: Calculation.</sec_outcome>
      <sec_outcome>Newborn's head circumference. Timepoint: Delivery time. Method of measurement: Tape.</sec_outcome>
      <sec_outcome>Polyhydramnios. Timepoint: End-of-trial. Method of measurement: Sonographic.</sec_outcome>
      <sec_outcome>Calcium. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Newborn's bilirubin. Timepoint: Delivery time. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.</sec_outcome>
      <sec_outcome>Newborns' hypoglycemia. Timepoint: After delivery. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Preterm delivery. Timepoint: After delivery. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>Maternal pre-eclampsia. Timepoint: After delivery. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>Maternal hospitalization. Timepoint: After delivery. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>Newborns' hospitalization. Timepoint: After delivery. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>LDL cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Arak University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Kashan University of Medical Sciences</source_name>
      <source_name>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-05-14</approval_date>
        <contact_name>Kashan University of Medical Sciences</contact_name>
        <contact_address>Bolvare Ghotbe Ravandi, Kashan Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
