<?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>IRCT20190402043157N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-19</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of simultaneous oral administration of vitamin D, zinc, calcium and magnesium on type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of combined oral supplementation  vitamin D, zinc, calcium and  magnesium  on glycemic control,  lipid profiles, liver enzymes and CRP index in Type 2 diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38676</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be divided into two groups based on the information obtained from them and stratified block randomization: the intervention group will be 39 and the control group will be 39, the intervention period will begin two months and after the preparation period, Blinding description: In this study, the researchers are participants and blind analyst, and the third one is outside the study, categorized and encoded by Mclarha, and the participants first start by identifying the work involved in the work There is no information about placebo or maclaques.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this two-month course, a double-blind, double-blind, oxidized zinc oxide 100 mg magnesium oxide and 400 mg calcium carbonate in the form of pills containing 200 units of vitamin D, 4 mg of zinc oxide, Which will be provided by the pharmaceutical company Raha farma in Isfahan. This supplement will be distributed under the supervision of the Ministry of Health at the pharmacies. Diabetes patients will once again take the supplements twice daily in the afternoon and in the afternoon. Intervention 2: Control group: During this two month period, the placebo will receive this supplement, which is a combination of Sorbitol Caryon, which is being prepared by the Pharmaceutical Company Rahafarma of Isfahan. Diabetes patients will once again take place twice a day once in the morning and next in the afternoon.</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 info</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mostafa badeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia, Resalat Blvd, Emergency Avenue</address>
        <city>urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>mostafabadeli@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mostafabadeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia, Resalat Blvd, Emergency Avenue</address>
        <city>urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>mostafabadeli@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adults (18 years of age and under 65 years of age)
People with type 2 diabetes who use the same drug (metformin, glibenclamide, metformin-repaglinide).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant and lactating people
People who are going to have a pregnancy
Smoking and alcohol
People with polycystic ovary syndrome (if accompanied by type 2 diabetes insulin resistance)
Having any underlying heart disease and cancer
Species that have kidney, liver and chronic diseases or acute inflammation (especially acute pancreatic inflammation) and thyroid gland diseases
Cystic fibrosis (malabsorption)
People with gastrointestinal diseases (celiac disease, Crohn's disease, peptic ulcer, diverticulosis, IBD, IBS)
People undergoing gastric bypass surgery (malabsorption)
People undergoing cholecystectomy (malabsorption)
Specimens that were under hormone therapy
Insulin injections (due to effect on body weight and insulin levels)
Change in the type and dosage of the medications consumed during the intervention
Not taking supplements (vitamin D and calcium, etc.) up to three months before the study
were treated with drugs and weight loss supplements (such as orlistat or dietary supplements)
People who use drugs that cause hyperglycaemia, such as oral or injectable corticosteroids (including prednisone, prednisolone, dexamethasone, triamcinolone, hydrocortisone or betamethasone)
People with diabetic foot ulcer
Change in the level of physical activity and intense physical activity</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this two-month course, a double-blind, double-blind, oxidized zinc oxide 100 mg magnesium oxide and 400 mg calcium carbonate in the form of pills containing 200 units of vitamin D, 4 mg of zinc oxide, Which will be provided by the pharmaceutical company Raha farma in Isfahan. This supplement will be distributed under the supervision of the Ministry of Health at the pharmacies. Diabetes patients will once again take the supplements twice daily in the afternoon and in the afternoon.</i_keyword>
      <i_keyword>Control group: During this two month period, the placebo will receive this supplement, which is a combination of Sorbitol Caryon, which is being prepared by the Pharmaceutical Company Rahafarma of Isfahan. Diabetes patients will once again take place twice a day once in the morning and next in the afternoon.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum insulin serum level (μIU / ml), 5. 10 ± 1.20 in the placebo group and 7.9 ± 2.7 in the intervention group. Timepoint: Measuring blood insulin at the beginning and end of the study. Method of measurement: Insulin ELISA will be measured.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total Cholesterol. Timepoint: Before and after intervention. Method of measurement: Dialab Kit Original Ultraviolet Auto analyzer BT-1500.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: Before and after intervention. Method of measurement: Dialab Kit Original Ultraviolet Auto analyzer BT-1500.</sec_outcome>
      <sec_outcome>HDL. Timepoint: Before and after intervention. Method of measurement: Dialab Kit Original Ultraviolet Auto analyzer BT-1500.</sec_outcome>
      <sec_outcome>LDL. Timepoint: Before and after intervention. Method of measurement: Dialab Kit Original Ultraviolet Auto analyzer BT-1500.</sec_outcome>
      <sec_outcome>VLDL. Timepoint: Before and after intervention. Method of measurement: Dialab Kit Original Ultraviolet Auto analyzer BT-1500.</sec_outcome>
      <sec_outcome>Physical activity. Timepoint: Before and after intervention. Method of measurement: questionnaire MET.</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Before and after intervention. Method of measurement: Mercury pressure gauge.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before and after intervention. Method of measurement: Mercury pressure gauge.</sec_outcome>
      <sec_outcome>BMI. Timepoint: Before and after intervention. Method of measurement: With the Inbody 770 Analyzer.</sec_outcome>
      <sec_outcome>Body composition. Timepoint: Before and after intervention. Method of measurement: With the Inbody 770 Analyzer.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: Before and after intervention. Method of measurement: Dialab Kit Original Ultraviolet Auto analyzer BT-1500.</sec_outcome>
      <sec_outcome>HbA1C. Timepoint: Before and after intervention. Method of measurement: Dialab Kit Original Ultraviolet Auto analyzer BT-1500.</sec_outcome>
      <sec_outcome>CRP. Timepoint: Before and after intervention. Method of measurement: Dialab Kit Original Ultraviolet Auto analyzer BT-1500.</sec_outcome>
      <sec_outcome>ALT. Timepoint: Before and after intervention. Method of measurement: Dialab Kit Original Ultraviolet Auto analyzer BT-1500.</sec_outcome>
      <sec_outcome>AST. Timepoint: Before and after intervention. Method of measurement: Dialab Kit Original Ultraviolet Auto analyzer BT-1500.</sec_outcome>
      <sec_outcome>GGT. Timepoint: Before and after intervention. Method of measurement: Dialab Kit Original Ultraviolet Auto analyzer BT-1500.</sec_outcome>
      <sec_outcome>ALP. Timepoint: Before and after intervention. Method of measurement: Dialab Kit Original Ultraviolet Auto analyzer BT-1500.</sec_outcome>
      <sec_outcome>HOMA-IR. Timepoint: Before and after intervention. Method of measurement: Through the formula.</sec_outcome>
      <sec_outcome>QUICKI. Timepoint: Before and after intervention. Method of measurement: Through the formula.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-18</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Urmia, Resalat Blvd, Emergency avenue Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
