<?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>IRCT20251118068041N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-02-16</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Effect of vitamin D in Thyroidectomy</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Effect of Preoperative Vitamin D on Postoperative Ionized Calcium Levels in Patients Undergoing Total Thyroidectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/87607</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each participant will be assigned a unique number. Then, by simple random draw, participants will be allocated to each group using simple random sampling, with the total sample equally divided into the control group (n=34) and the intervention group (n=34), Blinding description: Type of blinding: Double-blind;
Method of blinding: In this study, both patients and outcome assessors will be unaware of the intervention received by each participant; to maintain blinding, the vitamin D injections in the intervention group and no injection in the control group will be managed so that outcome assessors will not be aware of the differences, and the appearance of the injection process will be kept similar for both groups.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Patients with thyroid disorders who are candidates for total thyroidectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, patients will receive a single intramuscular injection of vitamin D3 at a dose of 15 micrograms (600 IU), purchased from Darou Pakhsh Pharmaceutical Company, two weeks before undergoing total thyroidectomy. Each patient will receive one injection. Intervention 2: Control group: In this group, patients will not receive any injection two weeks before surgery and will receive routine hospital care. No additional drugs or supplementary interventions will be provided.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Bagher Jahantab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gharani Blvd.</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>759113615</zip>
        <telephone>+98 74 3334 6079</telephone>
        <email>parsim90@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad Bagher Jahantab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qorani Blvd, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>759113615</zip>
        <telephone>+98 21 8670 5503</telephone>
        <email>parsim90@mail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 70 years
Candidates requiring total thyroidectomy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosis of diabetes mellitus
Use of systemic corticosteroids for more than 7 days within the past three months
Pregnancy
History of ischemic heart disease
Presence of any underlying disease affecting parathyroid hormone, vitamin D, calcium, or albumin levels (e.g., chronic kidney disease)
History of a major previous surgical procedure, such as total laryngectomy or parathyroidectomy
Substance abuse / drug addiction
Preoperative hypocalcemia
Change in the type of surgical
procedurePatients with intraoperative parathyroid injury, including cases where the surgeon reports injury, autotransplantation of parathyroid tissue, or evidence of parathyroid ischemia
Diagnosis of parathyroid adenoma before, during, or after surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E83.51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypocalcemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, patients will receive a single intramuscular injection of vitamin D3 at a dose of 15 micrograms (600 IU), purchased from Darou Pakhsh Pharmaceutical Company, two weeks before undergoing total thyroidectomy. Each patient will receive one injection.</i_keyword>
      <i_keyword>Control group: In this group, patients will not receive any injection two weeks before surgery and will receive routine hospital care. No additional drugs or supplementary interventions will be provided.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ionized calcium level after surgery. Timepoint: Every 12 hours for 2 days postoperatively (4 measurements). Method of measurement: Ionized calcium will be measured using standard laboratory biochemical assays.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hypocalcemia-related complications. Timepoint: Continuously monitored for 2 days postoperatively. Method of measurement: Assessed by clinical evaluation and patient monitoring.</sec_outcome>
      <sec_outcome>Requirement for additional calcium supplementation. Timepoint: During the 2-day postoperative period. Method of measurement: Recorded from patient treatment logs.</sec_outcome>
      <sec_outcome>Vitamin D levels. Timepoint: Measured at baseline and before surgery. Method of measurement: Measured using standard laboratory biochemical assays.</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>Yasuj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-08</approval_date>
        <contact_name>Ethics Committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Shahid Motahari Blvd., Yasuj Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
