<?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>IRCT20090822002365N22</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-30</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of vitamin D and omega 3 fatty acids co-supplementation on colorectal cancer</public_title>
      <acronym></acronym>
      <scientific_title>Effect of vitamin D, omega 3 fatty acids supplementation and co-supplementation of them on liver, inflammatory biomarkers, and oxidative stress in patients with colorectal cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36139</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks. According to the sample size of 80 subjects, 20 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug boxes that is generated by the software. Participants will enter based on the sequence produced into study and the drug packets with code registered will allocate to the individual. Therefore, before participants selection, they will be unaware of the type of intervention that will receive, as well as a random sequence produced during the study will be immune from prediction, Blinding description: For blinding, a person who is not involved in study protocol created the randomization list assigning participants to the vitamin D, omega-3, co-supplementation or the placebo group. Vitamin D, omega-3, and placebo tablets are placed into unlabeled identical containers. The study leader will label these containers with participant numbers using the randomization list. All investigators, and participants were blinded to the random assignments.</study_design>
      <phase>3</phase>
      <hc_freetext>Colorectal cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: a 50000 IU vitamin D tablet (Zahravi, Iran), weekly+ 2 omega-3 fatty acid capsules (each capsule containing 330 mg omega-3 fatty acid) (Minami Nutrition, Belgium), daily, for 8 weeks. Intervention 2: Intervention group 2: a 50000 IU vitamin D tablet (Zahravi, Iran), weekly+ 2 omega-3 fatty acid placebo (Zahravi, Iran), daily, for 8 weeks. Intervention 3: Intervention group 3: two omega-3 fatty acid capsules (each capsule containing 330 mg omega-3 fatty acid) (Minami Nutrition, Belgium), daily+ a vitamin D placebo (Zahravi, Iran), weekly, for 8 weeks. Intervention 4: Control group: a vitamin D placebo (Zahravi, Iran), weekly+ 2 omega-3 fatty acid placebo (Zahravi, Iran), daily, for 8 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
A part of the data will be shared, such as primary outcomes.

When:
4 months after the publication of the results.

To whom:
researchers and students of university.

Conditions:
Four months after the publication of this study papers, the obtained data will be available to the applicant researchers and students for further analysis.

Where to obtain:
Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com

How to obtain:
Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammadreza Vafa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Express way, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 8670 4734</telephone>
        <email>rezavafa@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammadreza Vafa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Express way, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 8670 4743</telephone>
        <email>rezavafa@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with stage ӀӀ or ӀӀӀ colorectal cancer and were candidate to receive chemotherapy;
aged 18 years or more;
body mass index range of 18.5-30 kg/m2;
serum 25(OH)D &lt; 30 ng/ml;
not having autoimmune or chronic diseases;
not taking vitamin D and/or omeaga-3 supplements and other vitamin- mineral supplements or parenteral nutrition;
not taking laxative and anti-inflammatory medications;
not allergic to fish and fish products;</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C18.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of colon, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: a 50000 IU vitamin D tablet (Zahravi, Iran), weekly+ 2 omega-3 fatty acid capsules (each capsule containing 330 mg omega-3 fatty acid) (Minami Nutrition, Belgium), daily, for 8 weeks.</i_keyword>
      <i_keyword>Intervention group 2: a 50000 IU vitamin D tablet (Zahravi, Iran), weekly+ 2 omega-3 fatty acid placebo (Zahravi, Iran), daily, for 8 weeks.</i_keyword>
      <i_keyword>Intervention group 3: two omega-3 fatty acid capsules (each capsule containing 330 mg omega-3 fatty acid) (Minami Nutrition, Belgium), daily+ a vitamin D placebo (Zahravi, Iran), weekly, for 8 weeks.</i_keyword>
      <i_keyword>Control group: a vitamin D placebo (Zahravi, Iran), weekly+ 2 omega-3 fatty acid placebo (Zahravi, Iran), daily, for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum level of TNF-α. Timepoint: Before and 8 weeks after intervention. Method of measurement: Serum TNF-α levels will be assessed by ELISA and Bender Med kit (Bender Med, Germany).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum levels of Matrix Metalloproteinase-2 (MMP-2). Timepoint: Before and 8 weeks after intervention. Method of measurement: Serum levels of MMP-2 will be assessed by ELISA and Zellbio kit (Zellbio, Germany).</sec_outcome>
      <sec_outcome>Serum levels of Matrix Metalloproteinase-9 (MMP-9). Timepoint: Before and 8 weeks after intervention. Method of measurement: Serum levels of MMP-9 will be assessed by ELISA and Zellbio kit (Zellbio, Germany).</sec_outcome>
      <sec_outcome>Serum levels of Alkaline phosphatase (ALP). Timepoint: Before and 8 weeks after intervention. Method of measurement: Serum levels of ALP will be assessed by ELISA and Zellbio kit (Zellbio, Germany).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-13</approval_date>
        <contact_name>Ethics committee of Iran University of Medical of Sciences</contact_name>
        <contact_address>Iran University of Medical Science, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
