<?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>IRCT20201130049548N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-19</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of zinc and omega-3 supplementation effect on maternal and fetal outcomes in pregnant women with IUGR fetus</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of zinc and omega-3 supplementation effect on maternal and fetal outcomes in pregnant women with IUGR fetus with control group, a double-blind placebo controlled clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>117</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53052</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: We use the block randomization method to randomize subjects into groups that result in equal sample sizes. 
We use the block size 6. From the following blocks, first select 1 by accident and divide the samples into three groups according to the order and fill the blocks
A for zinc supplementation  and B for omega-3 supplementation and C for placebo

C	C	B	B	A	A	1

A	C	C	B	B	A	2

A	A	C	C	B	B	3

B	A	A	C	C	B	4

B	B	A	A	C	C	5

C	A	A	B	B	C	6, Blinding description: This study is double-blind and the medical examiner resident , medication provider and patients would not know about the type of treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: neonatal weight. Condition 2: Apgar score.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Zinc supplement recipients (zinc supplement in the form of tablets containing 30 mg of zinc sulfate daily for 6 weeks produced by Dineh Pharmaceutical Company). Intervention 2: Intervention group: Omega-3 supplement recipients (omega-3 supplement in the form of a tablet containing 180 mg EPA eicosopentaanoic acid and 120 mg docosahexaenoic acid DHA at a dose of 120 mg  daily for 6 weeks produced by Zahravi Pharmaceutical Company). Intervention 3: Control group: Placebo recipients (made by Barij Essential Company daily for 6 weeks).</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mona Babooei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Shast Kola Road, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4934174515</zip>
        <telephone>+98 17 3220 2565</telephone>
        <email>dr.babooie@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mona Babooei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Shast Kola Road, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4934174515</zip>
        <telephone>+98 17 3220 2565</telephone>
        <email>dr.babooie@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women aged 18-35 years
Pregnant women with a gestational age of more than 20 weeks
Pregnant women with IUGR-based fetal sonography
Maternal body mass index between 15 to 30 kg / m2
No history of allergies to fish and omega 3
Complete patient information
Satisfaction to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Multiple pregnancies
Underlying diseases such as diabetes and high blood pressure
Existence of structural disorders of the uterus
Maternal addiction and smoking
Chronic infection (dehydration, fever)
Chronic liver and kidney disease
placenta previa or decollement</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Zinc supplement recipients (zinc supplement in the form of tablets containing 30 mg of zinc sulfate daily for 6 weeks produced by Dineh Pharmaceutical Company)</i_keyword>
      <i_keyword>Intervention group: Omega-3 supplement recipients (omega-3 supplement in the form of a tablet containing 180 mg EPA eicosopentaanoic acid and 120 mg docosahexaenoic acid DHA at a dose of 120 mg  daily for 6 weeks produced by Zahravi Pharmaceutical Company)</i_keyword>
      <i_keyword>Control group: Placebo recipients (made by Barij Essential Company daily for 6 weeks)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Better neonatal weight gain. Timepoint: Neonatal weight at birth time. Method of measurement: Measuring the weight of a newborn baby with a digital scale.</prim_outcome>
      <prim_outcome>Apgar score. Timepoint: 5th minute Apgar score. Method of measurement: Based on Apgar scale.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-15</approval_date>
        <contact_name>Ethics Committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Golestan University of Medical Sciences, Gorgan,Shastkola road, Philosophical Higher Education Complex Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
