<?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>IRCT201408295623N26</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-05</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of zinc in treatment of gestational diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Effect of zinc supplementation on insulin resistance and lipid profiles in women with gestational diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6056</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline after balanced blocked randomisation, participants will be allocated into two treatment groups to take either zinc supplements (n = 29) or placebo (n = 29). 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, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic who is not involved in the trial and not aware of random sequences will allocate the numbered bottles of capsules to participants. Supplements and placebo are in the same packaging at the 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>3</phase>
      <hc_freetext>Gestational diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Zinc capsule (Donyayeh Behesht Pharmaceutical Company, Tehran, Iran), 30 mg, once a day for 6 weeks orally. Intervention 2: Control group: Placebo capsule (Barij Essence Pharmaceutical Company, Kashan, Iran), once a day 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>1771844351</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>1771844351</zip>
        <telephone>+98 31 5546 3378</telephone>
        <email>asemi_r@yahoo.com</email>
        <affiliation>Kashan University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Pregnant women aged 18-40 years diagnosed with gestational diabetes mellitus at 24-28 weeks' gestation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Taking zinc supplements
Premature preterm rupture of membrane
Placenta abruption
Pre-eclampsia
Eclampsia
Chronic hypo- and hypothyroidism
The use of substitute treatments including hormone or vitamin supplements
Complete bed rest (CBR)
Intra uterine fetal death (IUFD)
Preterm delivery</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: Zinc capsule (Donyayeh Behesht Pharmaceutical Company, Tehran, Iran), 30 mg, once a day for 6 weeks orally.</i_keyword>
      <i_keyword>Control group: Placebo capsule (Barij Essence Pharmaceutical Company, Kashan, Iran), once a day for 6 weeks orally.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Insulin. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Eliza.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Calculation with HOMA formula.</prim_outcome>
      <prim_outcome>Hs-CRP. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Eliza.</prim_outcome>
      <prim_outcome>Newborns PPAR-gamma. Timepoint: Cord blood of newborns of women with GDM at delivery time. Method of measurement: PCR-RT.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>HDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>VLDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>LDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Total antioxidant capacity. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Nitric oxide. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Newborns' weight. Timepoint: The first 24 h after birth. Method of measurement: Scale.</sec_outcome>
      <sec_outcome>Newborn length. Timepoint: The first 24 h after birth. Method of measurement: Girth measuring tape.</sec_outcome>
      <sec_outcome>Newborn head circumference. Timepoint: The first 24 h after birth. Method of measurement: Girth measuring tape.</sec_outcome>
      <sec_outcome>Polyhydramnios. Timepoint: After 6 weeks of intervention. Method of measurement: Sonography.</sec_outcome>
      <sec_outcome>Newborns glucose transporter 1 (GLUT1). Timepoint: Cord blood of newborns of women with GDM at delivery time. Method of measurement: PCR-RT.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Kashan 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>Arak University of Medical Sciences</source_name>
      <source_name>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-03</approval_date>
        <contact_name>Arak University of Medical Sciences</contact_name>
        <contact_address>Vice-chancellor for Education and Research, 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>
