<?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>IRCT2013072814195N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-09-05</date_registration>
      <primary_sponsor>Vice chancellor for research Lorestan University of Medical Sciences</primary_sponsor>
      <public_title>Vitamin D supplementation and obesity</public_title>
      <acronym></acronym>
      <scientific_title>Effect of vitamin D supplementation on anthropometric indices and  lipid profile among overweight and obese women : A  Placebo-controlled  Randomized   Clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13846</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: patients will be randomly assigned into case and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: obesity. Condition 2: overweight.</hc_freetext>
      <i_freetext>Intervention 1: Patients in the control group receive oral placebo  which are specifically designed to have no real effect. They are made of lactose.These pearls  in terms of size, shape, packaging and name are exactly similar to the vitamin D pearls. Only the code written on the boxes are different from each other. Frequency and duration of using placebo pearls in the control group are absolutely the same as vitamin D pearls in the intervention group.  One pearl will be given to the patients every 25 days until 4 doses.  The pearls will be prepared from Daana Pharma Company. Intervention 2: Oral vitamin D supplement ( pearl ) 2000 IU/ d ( = 50 μg/d as cholecalciferol ) will be given to the intervention group until 3 months. Each pearl contains 50000 IU vitamin D3. One pearl will be given to the patients every 25 days until 4 doses. The pearls will be prepared from Daana Pharma Company.</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>Mohammad Hasan Kayedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vice chancellor for research and technology, Lorestan University of Medical Sciences, Kamalvand Street, Khoramabad, Lorestan, Iran</address>
        <city>Khoramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 66 1331 0771</telephone>
        <email>kayedi@lums.ac.ir</email>
        <affiliation>Vice chancellor for research and technology of Lorestan University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahim Falahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition department, Paramedics Don, Goldasht Street, Khoramabad, Lorestan, Iran</address>
        <city>Khoramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 66 1420 9971</telephone>
        <email>falahi.e@lums.ac.ir       e_falahi@yahoo.com</email>
        <affiliation>Lorestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age of 18-70 and  BMI&gt;25&#13;
Exclusion criteria: to have  history of vitamin D deficiency,diabetes mellitus,thyroid disorders, hyperlipidemia,cardiac diseases and use of vitamins and mineral supplements.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
      <hc_keyword>Obesity, 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>Patients in the control group receive oral placebo  which are specifically designed to have no real effect. They are made of lactose.These pearls  in terms of size, shape, packaging and name are exactly similar to the vitamin D pearls. Only the code written on the boxes are different from each other. Frequency and duration of using placebo pearls in the control group are absolutely the same as vitamin D pearls in the intervention group.  One pearl will be given to the patients every 25 days until 4 doses.  The pearls will be prepared from Daana Pharma Company.</i_keyword>
      <i_keyword>Oral vitamin D supplement ( pearl ) 2000 IU/ d ( = 50 μg/d as cholecalciferol ) will be given to the intervention group until 3 months. Each pearl contains 50000 IU vitamin D3. One pearl will be given to the patients every 25 days until 4 doses. The pearls will be prepared from Daana Pharma Company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body Mass Index (BMI). Timepoint: before intervention and 3 months after study. Method of measurement: balance-meter.</prim_outcome>
      <prim_outcome>Waist to Hip ratio (W/H). Timepoint: before intervention and  3 months after study. Method of measurement: meter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total cholesterol. Timepoint: before  intervention and 3 months after study. Method of measurement: spectrophotometer.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: before  intervention and 3 months after study. Method of measurement: spectrophotometer.</sec_outcome>
      <sec_outcome>Low density lipoprotein ( LDL). Timepoint: Before  intervention and 3 months after study. Method of measurement: Spectrophotometer.</sec_outcome>
      <sec_outcome>High density lipoprotein (HDL). Timepoint: before  intervention and 3 months after study. Method of measurement: spectrophotometer.</sec_outcome>
      <sec_outcome>Serum 25 hydroxyvitamin D. Timepoint: Before  intervention and 3 months after study. Method of measurement: IBL company laboratory kit.</sec_outcome>
      <sec_outcome>Serum calcium. Timepoint: Before intervention  and 3 months after study. Method of measurement: Spectrophotometer.</sec_outcome>
      <sec_outcome>Serum phosphorus. Timepoint: Before  intervention and 3 months after study. Method of measurement: spectrophotometer.</sec_outcome>
      <sec_outcome>Parathyroid hormone (PTH). Timepoint: Before intervention and 3 months after study. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Received energy. Timepoint: 3 days during the intervention. Method of measurement: Questionnaire and N4 software.</sec_outcome>
      <sec_outcome>Received calcium. Timepoint: 3 days during the intervention. Method of measurement: Questionnaire and N4 software.</sec_outcome>
      <sec_outcome>Received phosphorus. Timepoint: 3 days during the intervention. Method of measurement: Questionnaire and N4 software.</sec_outcome>
      <sec_outcome>Received vitamin D. Timepoint: 3 days during the intervention. Method of measurement: Questionnaire and N4 software.</sec_outcome>
      <sec_outcome>Received nutrient elements. Timepoint: 3 days during the intervention. Method of measurement: Questionnaire and N4 software.</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 Lorestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-06-01</approval_date>
        <contact_name>Ethics committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research and technology, Lorestan University of Medical Sciences, Kamalvand Street, Khoramabad, Lorestan, Iran Khoram abad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
