<?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>IRCT2014112720114N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-06-09</date_registration>
      <primary_sponsor>Yazd Shahid Sadoughi University of Medical Sciences</primary_sponsor>
      <public_title>The effects of oat bran supplementation on glycemic profile in patients with gestational diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effects of oat bran supplementation on glycemic profile in patients with gestational diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-12-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17854</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>gestational diabetes.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group consumed 30 grams of oat bran of the  lunch and dinner with 100 grams of yogurt and a diet consistent with ADA. Intervention 2: The control group consumed 100 grams of yogurt in lunch and dinner and a diet consistent with ADA.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>dr Azade Najarzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi University of Medical Sciences, Imam Hossein square, Yazd</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916189165</zip>
        <telephone>+98 35 3624 0691</telephone>
        <email>azmm1383@yshoo.COM</email>
        <affiliation>Yazd Shahid Sadoughi University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr Azade Najarzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi University of Medical Sciences, Imam Hossein square, Yazd</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916189165</zip>
        <telephone>+98 35 3624 0691</telephone>
        <email>azmm1383@yahoo.com</email>
        <affiliation>Yazd Shahid Sadoughi University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Eligible participants were 20-40 years singleton pregnant women with &lt;34 weeks gestation, whose GDM were detected by an endocrinologist based on one-step approach, as proposed by the IADPSG, that is, fasting blood glucose ≥ 92 mg dˉ¹ or one hour glucose after ingestion of 75 g glucose ≥180 mg dˉ¹, or two hour glucose ≥ 153 mg dˉ¹(19). Women with pre-gestational diabetes and chronic medical conditions including heart, kidney and gestational diseases or high blood pressure were excluded from the study. Other exclusion criteria included having celiac or allergic reactions to oat bran, lactation during the past three months, and unwillingness to follow the prescribed diet</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus in pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group consumed 30 grams of oat bran of the  lunch and dinner with 100 grams of yogurt and a diet consistent with ADA</i_keyword>
      <i_keyword>The control group consumed 100 grams of yogurt in lunch and dinner and a diet consistent with ADA</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FBS. Timepoint: Before Intervention and four week after Intervention. Method of measurement: enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>Fructose amin. Timepoint: Before Intervention and four week after Intervention. Method of measurement: enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>HbA1C. Timepoint: Before Intervention and four week after Intervention. Method of measurement: enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>2hhp. Timepoint: Before Intervention and four week after Intervention. Method of measurement: enzymatic method, mg/dl.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Before Intervention and four week after Intervention. Method of measurement: scale, kg.</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>Yazd Shahid Sadoughi University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-26</approval_date>
        <contact_name>Ethics Committee of the University of Medical Sciences</contact_name>
        <contact_address>Imam Reza integrated, Blvd student, Yazd Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
