<?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>IRCT20161022030424N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-12</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>vitamin D3 and flaxseed oil supplementation effects in type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the effect of high-dose vitamin D3 with alpha linoleic acid (flaxseed oil) supplementation on serum indices of inflammation and oxidative stress in the elderly with type 2 diabetes.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71581</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A block randomization method will be used to allocate participants to the groups with a 1:1 allocation using random allocation software (RAS) with block sizes of 2and 4. Similarly sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package, Blinding description: Intervention and placebo supplements will be prepared in exactly the same way in terms of shape, color, and odor, and will be placed in a small envelope containing 8 and 168 tablets for each participant for 8 weeks consumption. The envelopes will be opened in the order in which the participants enter this stage from number 1, and an envelope containing the supplement will be provided to the participant for 8 weeks. Outcome assessors, the person responsible for statistical analysis of the data, and the respondents will be blinded to the type of supplement received until the end of the study.</study_design>
      <phase>3</phase>
      <hc_freetext>Type 2 diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: vitamin D3 supplements at 50,000 IU per week and 1000 mg of flaxseed oil soft gel(made by Barij esans company) three times a day for 8 weeks. Intervention 2: Control group: flaxseed oil soft gel placebo three times a day and a vitamin D3 placebo once weekly 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>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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda Dolatkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Str., Azadi Ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614756</zip>
        <telephone>+98 41 3336 1928</telephone>
        <email>dolatkhahn@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda Dolatkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Reza hospital, Golgasht Str., Azadi Ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5163995479</zip>
        <telephone>+98 41 3336 1928</telephone>
        <email>neda_dolatkhah@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>the age of 65 and above
the patient has been diagnosed with type 2 diabetes based on medical records
hemoglobin A1C level is between 10-5/6
anti-diabetic treatment, which has not been changed for at least 8 weeks
25-hydroxy vitamin D3 level between 125-30 nano moles per liter</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Type 1 diabetes
Smoking and alcohol consumption
Severe uncontrolled diabetes
Severe uncontrolled blood pressure
Lack of interest in continuing the study
Unusual stress event during the study
25-hydroxy vitamin D3 level less than 30 and higher than 125 nano moles per liter</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</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>Intervention group: vitamin D3 supplements at 50,000 IU per week and 1000 mg of flaxseed oil soft gel(made by Barij esans company) three times a day for 8 weeks</i_keyword>
      <i_keyword>Control group: flaxseed oil soft gel placebo three times a day and a vitamin D3 placebo once weekly for 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum concentration of inflammatory indices (hs-CRP). Timepoint: Measurement of the serum levels of inflammatory markers at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil)  supplementation. Method of measurement: Biochemical analysis.</prim_outcome>
      <prim_outcome>Serum concentration of oxidative stress indices (MDA and TAC). Timepoint: Measurement of the serum levels of inflammatory markers at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil)  supplementation. Method of measurement: Biochemical analysis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anthropometric indices. Timepoint: Measurement of the anthropometric indices at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: Seca digital scale.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Evaluation of the quality of life at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: SF-36 quality of life questionnaire.</sec_outcome>
      <sec_outcome>Metabolic indices(triglycerides, LDL cholesterol). Timepoint: Measurement of Metabolic indices(triglycerides, LDL cholesterol) at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: Biochemical analysis.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-12</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
