<?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>IRCT201507035623N47</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-19</date_registration>
      <primary_sponsor>Vice chancellor for research, Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of supplementation in treatment of gestational diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of the effect of combined omega-3 and vitamin E supplementation on pregnancy outcomes in gestational diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6077</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline and after stratification for pre-intervention BMI and weeks of gestation, subjects will be randomly divided into two groups to take combined omega-3 and vitamin E supplementation (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers, Blinding description: Participants, investigators or the assessors of the outcomes are unaware of the study groups. Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the gynecology clinic, 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 placebos capsules are similar in shape and size.</study_design>
      <phase>3</phase>
      <hc_freetext>Gestational diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Combined omega-3 and vitamin E pearl, 1000 mg omega-3 and 400 IU vitamin E, daily, for 6 weeks orally. Intervention 2: Control group: Placebo pearl, daily, 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 5546 3378</telephone>
        <email>asemi_z@kaums.ac.ir</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>81151-87159</zip>
        <telephone>+98 31 5546 3378</telephone>
        <email>asemi_z@kaums.ac</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
Diagnosed with GDM at 24-28 week gestation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Placenta abruption
Preeclampsia
Eclampsia
Hypo- and hyperthyroidism
Urinary tract infection
Smokers
Kidney or liver diseases</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: Combined omega-3 and vitamin E pearl, 1000 mg omega-3 and 400 IU vitamin E, daily, for 6 weeks orally.</i_keyword>
      <i_keyword>Control group: Placebo pearl, daily, for 6 weeks orally.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Glutathione. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Hs-CRP. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa.</prim_outcome>
      <prim_outcome>Nitric oxide. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Newborn length. Timepoint: The first 24 h after birth. Method of measurement: Scale.</sec_outcome>
      <sec_outcome>Newborns' weight. Timepoint: The first 24 h after birth. Method of measurement: Scale.</sec_outcome>
      <sec_outcome>Polyhydramnios. Timepoint: After the intervention. Method of measurement: Sonography.</sec_outcome>
      <sec_outcome>Newborn's head circumference. Timepoint: Delivery time. Method of measurement: Tape.</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>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>
    </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, Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-08</approval_date>
        <contact_name>Ethicc's committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
