<?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>IRCT201301182709N27</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-03-24</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences and Health services</primary_sponsor>
      <public_title>The effect of iron and omega-3 on coronary heart disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of supplementation with iron alone and combined with the docosahexaenoic acid  and changes in serum lipid profile on risk of Coronary- heart disease via measuring paraoxonase 1, hs-CRP and the ApoB / ApoA1 ratio in women with iron deficiency anemia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2540</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Iron deficiency anaemia. Condition 2: Iron deficiency anaemia.</hc_freetext>
      <i_freetext>Intervention 1: Group df or intervention: Patients with iron deficiency anemia that is based on sharing random daily receive capsule supplement DHA-containing (465 mg DHA + 63 mg EPA) + a tablet into sulfate containing 50 mg elemental iron for 12 weeks . Intervention 2: Group or the control pf: People with iron-deficiency anemia that is based on sharing a random day a number of placebo capsules containing 500 mg of corn oil + a tablet of sulfate contains 50 mg of elemental iron for 12 weeks to receive .</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>Samira Amani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>not the bottom left deadlocked belt last, Alley Rajai martyr, Tehran St, Ghaemshahr, Mazandaran, Iran</address>
        <city>Ghaemshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+1 232370630</telephone>
        <email>s.amani5n@gmail.com</email>
        <affiliation>Tehran University of Medical Therapy</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>F. Shidfar doctor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences, Department of Nutrition and Diet, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8877 9118</telephone>
        <email>f-shidfar@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: • Serum ferritin less than 12 ϻ g / l and serum iron of 60 mcg/100ml • Women in the range of 15 to 45 years of age • regular menstrual cycles • willingness to cooperate and fill the criteria of informed consent form to the project exclusion criteria: • smoking tobacco or alcohol • iron supplements, multivitamins and antioxidants in the last three months • the use of lipid-lowering drugs, oral contraceptives • the use of oral contraceptives • parasitic infections (those who have been diagnosed positive stool test will be excluded.) • thalassemia disease • kidney disease, liver disease, diabetes • local or systemic infection or inflammatory disease • history of ulcer disease or gastrointestinal bleeding or fibroids •malabsorption such as celiac sprue or steatorrhea • Any type of blood transfusion in the last 2 months of • pregnancy or lactation • not wanting to continue working • inadequate compliance supplement (compliance less than 80%) • change in diet or physical activity for any reason</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D50.9</hc_code>
      <hc_code>D50.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Iron deficiency anaemia, unspecified</hc_keyword>
      <hc_keyword>Other iron deficiency anaemias</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group df or intervention: Patients with iron deficiency anemia that is based on sharing random daily receive capsule supplement DHA-containing (465 mg DHA + 63 mg EPA) + a tablet into sulfate containing 50 mg elemental iron for 12 weeks .</i_keyword>
      <i_keyword>Group or the control pf: People with iron-deficiency anemia that is based on sharing a random day a number of placebo capsules containing 500 mg of corn oil + a tablet of sulfate contains 50 mg of elemental iron for 12 weeks to receive .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting serum ferritin. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: According ϻ g / l Lyazvn method.</prim_outcome>
      <prim_outcome>Paraoxonase 1 activity. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: By U / L spectrophotometry.</prim_outcome>
      <prim_outcome>Fasting serum ApoB levels. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Based on Mg / dl Turbydymtry method.</prim_outcome>
      <prim_outcome>Fasting serum concentrations of ApoA1. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Based on Mg / dl Turbydymtry method.</prim_outcome>
      <prim_outcome>Fasting concentrations of serum HS-CRP. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Based on Mg / l immunohistochemical method Flumtryk.</prim_outcome>
      <prim_outcome>Fasting serum iron. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: According ϻ g / dl spectrophotometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body mass index. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Kg/m2 calculated based on the height and weight.</sec_outcome>
      <sec_outcome>Age. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: In terms of the question.</sec_outcome>
      <sec_outcome>Energy intake. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (kcal / day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Carbohydrate intake. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (g/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Protein intake. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (g/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Fat intake. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (g/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Fiber intake. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (g/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Vitamin A. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (mg/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Vitamin C. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (mg/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Vitamin E. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (mg/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Betacarotene. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (mg/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Iron. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (mg/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Zinc. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (mg/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Selenium. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (mg/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Copper. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (mg/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Sodium. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (mg/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Potassium. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (mg/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Kind of fat. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: Terms (mg/day) over a 24-hour dietary questionnaire.</sec_outcome>
      <sec_outcome>Level of physical activity. Timepoint: Before the experiment, 12 weeks after intervention. Method of measurement: In terms of intensity (light, medium and heavy) information through a questionnaire.</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>Tehran University of Medical Sciences and Health services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-18</approval_date>
        <contact_name>Tehran University of Medical Sciences &amp; Health Services</contact_name>
        <contact_address>Tehran, Department of Nutrition and Diet, Tehran University of Medical Sciences Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
