<?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>IRCT20250207064676N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-02</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Studying the effect of vitamin D on benign paroxysmal positional vertigo (BPPV)</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effects of vitamin D in patients with benign paroxysmal positional vertigo (BPPV)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82442</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple random selection method using a random number table will be used to select individuals.
In this way, the researcher first determines the direction of movement in the table and then randomly places her finger on one of the numbers in the table.
Then it moves in the direction indicated in the table and records all the numbers.
Even numbers will receive the intervention method and odd numbers the control method.</study_design>
      <phase>3</phase>
      <hc_freetext>benign paroxysmal positional vertigo(bppv).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group : In the intervention group, in addition to standard BPPV treatment (Epley maneuver It is a treatment method performed by a physician and involves a series of four head and body movements from  sitting to lying down, rolling to the side, and returning to a sitting position.), one 1000-unit vitamin D supplement tablet (Dana Pharma) is prescribed once daily with food until the end of the study (6 months).  The dose of vitamin D used in this study is within the daily requirement and completely safe. Intervention 2: Control group: In this group, only the Epley maneuver is performed, which is the standard treatment, and vitamin D supplementation is not prescribed, and the patient is advised not to take vitamin D until the end of the study.</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 Information may be published after collection and verification.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abas Rezaeezade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Block332, Daneshjoo street ,Velayat city ,Babaei Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1698749511</zip>
        <telephone>+98 83 4814 2376</telephone>
        <email>arezaeezade72a91@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abas Rezaeezade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Block332, Daneshjoo street, Velayat city, Babaei Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1698741195</zip>
        <telephone>+98 83 4814 2376</telephone>
        <email>arezaeezade72a91@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with confirmed benign paroxysmal positional vertigo (BPPV)
Over 18 years old
Serum vitamin D levels should be between 30 and 50</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to complete the informed consent form
Taking drugs that affect vitamin D metabolism
History of ear surgery
History of Meniere's disease
History of labyrinthitis or vestibular neuritis
Pregnancy or breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H81.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Benign paroxysmal vertigo</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 : In the intervention group, in addition to standard BPPV treatment (Epley maneuver It is a treatment method performed by a physician and involves a series of four head and body movements from  sitting to lying down, rolling to the side, and returning to a sitting position.), one 1000-unit vitamin D supplement tablet (Dana Pharma) is prescribed once daily with food until the end of the study (6 months).  The dose of vitamin D used in this study is within the daily requirement and completely safe.</i_keyword>
      <i_keyword>Control group: In this group, only the Epley maneuver is performed, which is the standard treatment, and vitamin D supplementation is not prescribed, and the patient is advised not to take vitamin D until the end of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of attacks of benign paroxysmal positional vertigo. Timepoint: Evaluation of benign paroxysmal positional vertigo before intervention and one month, three months, and six months after intervention. Method of measurement: Patient history in the form of a checklist and Hall-Pike maneuver (which is a diagnostic maneuver).</prim_outcome>
      <prim_outcome>Time interval between attacks of benign paroxysmal positional vertigo. Timepoint: Evaluation of benign paroxysmal positional vertigo before intervention and one month, three months, and six months after intervention. Method of measurement: Patient history in the form of a checklist and Hall-Pike maneuver (which is a diagnostic maneuver).</prim_outcome>
      <prim_outcome>Duration of benign paroxysmal positional vertigo attack. Timepoint: Evaluation of benign paroxysmal positional vertigo before intervention and one month, three months, and six months after intervention. Method of measurement: Patient history in the form of a checklist and Hall-Pike maneuver (which is a diagnostic maneuver).</prim_outcome>
      <prim_outcome>Severity of benign paroxysmal positional vertigo attacks. Timepoint: Evaluation of benign paroxysmal positional vertigo before intervention and one month, three months, and six months after intervention. Method of measurement: Patient history in the form of a checklist and Hall-Pike maneuver (which is a diagnostic maneuver).</prim_outcome>
      <prim_outcome>Symptoms associated with benign paroxysmal positional vertigo. Timepoint: Evaluation of benign paroxysmal positional vertigo before intervention and one month, three months, and six months after intervention. Method of measurement: Patient history in the form of a checklist and Hall-Pike maneuver (which is a diagnostic maneuver).</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-20</approval_date>
        <contact_name>Ethics Committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>Baqiyatollah University , Molla Sadra Street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
