<?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>IRCT20200105046012N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-03</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of relationship between vitamin D supplementation treatment and hypercalciuria in patients with kidney stones</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of relationship between vitamin D supplementation treatment and hypercalciuria in patients with kidney stones</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44832</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients will be done by the responsible researcher using a table of random numbers Randomization will be recorded on an Excel file by the principal investigator. Participants will be randomized via permuted block randomization. Each block will be consistent of  sizes of 4 patients. For assignment of each patient to the drug or placebo group, for each patients a unique code consistent of 2 letters and a digit will be assigned. the code will be unique for each patient ( for example code AB1 for first patient). Only the principle investigator will be informed of the assignment of each code to the medication or placebo group, Blinding description: 1- The nurse who gives the medication to the patients whether or not they are on the medication is not aware
Patients were or were not aware of the drug
3. The laboratory does not know which sample belongs to the control group.</study_design>
      <phase>3</phase>
      <hc_freetext>Hypercalciuria in patients with kidney stones.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: People with kidney stones who have vitamin D levels below 30 ng / ml are prescribed oral vitamin D 50,000 units weekly for up For each patient, training sessions are held before and after the intervention, and in this study, the product of Zahravi Company is used.to 8 weeks. Intervention 2: Control group: People with kidney stones who have vitamin D levels below 30 ng / ml are given weekly placebo for up to 8 weeks.For each patient, training sessions are held before and after the intervention, and in this study, the product of Zahravi Company is used.</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:
The whole potential data is unpublished after being unidentifiable

When:
Start the access period 6 months after printing the results

To whom:
Only available to scholars working in academic and academic institutions

Conditions:
Use of study data is permitted for any use by researchers working in academic and scientific institutions

Where to obtain:
Ali ebn Abitalib Hospital, Zahedan, Department of intral Deputy of Research of Zahedan University of Medical Sciences, Faculty of Medicine Dr. Ali Alidadi, professor of the thesis, telephone number 09120621590

How to obtain:
It takes about 1 month from the request of the applicant to access data files or time documentation

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>elham javadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Bin Abi Talib Hospital ., Persian Gulf Highway ., Zahedan town ., sistan and Baluchestan province</address>
        <city>zahedan</city>
        <country1>Ireland</country1>
        <zip>9816743111</zip>
        <telephone>+98 54 3329 5575</telephone>
        <email>elham.javadian1396@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>elham javadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Bin Abi Talib Hospital ., Persian Gulf Highway ., Zahedan town ., sistan and Baluchestan province</address>
        <city>Zahedan</city>
        <country1>Ireland</country1>
        <zip>9816743111</zip>
        <telephone>05433295570</telephone>
        <email>elham.javadian1396@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- Patients with kidney stones and vitamin D deficiency referred to Zahedan Nephrology Clinic
- People aged 18-65 years
Acceptance to participate in the project
Lack of specific illnesses such as heart failure, kidney or liver disease
Absence of inflammatory or infectious diseases
Not taking medications like diuretics
Not taking corticosteroids
Not taking immunosuppressive drugs
Not taking vitamin D supplement before study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>- Medication including drugs such as diuretics, potassium citrate
- Pregnant women
- Recent stone disposal
Ureteral stone leads to obstruction
Urinary tract infection for the last two weeks
- Systemic infection in the last two weeks</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: People with kidney stones who have vitamin D levels below 30 ng / ml are prescribed oral vitamin D 50,000 units weekly for up For each patient, training sessions are held before and after the intervention, and in this study, the product of Zahravi Company is used.to 8 weeks.</i_keyword>
      <i_keyword>Control group: People with kidney stones who have vitamin D levels below 30 ng / ml are given weekly placebo for up to 8 weeks.For each patient, training sessions are held before and after the intervention, and in this study, the product of Zahravi Company is used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Increased urinary calcium level. Timepoint: 24-hour urine calcium measurement at baseline (before intervention) and 3 months after intervention. Method of measurement: Laboratory measurement.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-04</approval_date>
        <contact_name>Ethics committee of zahedan  University of Medical Sciences</contact_name>
        <contact_address>Sistan and Baluchestan Zahedan - Persian Gulf Highway - Imam Khomeini Mosque - Ali Bin Abi Talib Hospital Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
