<?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>IRCT20210716051908N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of vitamin D supplementation in reducing vertigo attacks and severity in Meniere’s patients, A Randomized Double-Blind Clinical Trial with Placebo-Controlled</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of vitamin D supplementation in reducing vertigo attacks and severity in Meniere’s patients, A Randomized Double-Blind Clinical Trial with Placebo-Controlled</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57646</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomly assigned to one of two groups of vitamin D supplements and placebo based on the permuted block randomization method, which will use 6 blocks, Blinding description: A person other than the researcher who does not have information on how to perform and the purpose of the study will use a list of random numbers to encode the vitamin D supplement and placebo and will be numbered according to the list so that the researcher does not know the type of supplements. Participants will also have no information about the contents of the package.</study_design>
      <phase>3</phase>
      <hc_freetext>meniere disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to receiving the usual Meniere treatment (betahistine) , Pearl Vitamin D supplement 50,000 units, one per week, after lunch and for 8 weeks will be prescribed. Intervention 2: Control group: The placebo, which is exactly the same as the vitamin D supplement in shape and color, will be delivered once a week, after lunch, 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poursina Ave, District 6, Tehran University of Medical Sience, pharmacy facualty</address>
        <city>Tehra</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>02164120</telephone>
        <email>alitph8@gmmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poursina Ave, District 6, Tehran University of Medical Sience, Pharmacy Facualty</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>02164120</telephone>
        <email>alitph8@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with a definitive diagnosis of MD according to the guidelines of the American Academy of Otolaryngology (AAO-HNS) (≥ 2 episodes of spontaneous vertigo, each lasting at least 20 minutes to 12 hours, along with an audiometric test that Indicates sensorineural hearing loss in the ear involved in low frequency and clinical symptoms such as tinnitus, feeling of fullness of the ear)
Age over 18 years
Serum levels of 25 (OH) vitD3 less than 30 ng / ml and more than 10 ng / ml</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Serum levels of 25 (OH) vitD3 less than 10 ng / ml
Consumption of drugs that affect absorption and metabolism of vitamin D (such as: carbamazepine, phenytoin, phenobarbital, rifampin, glucocorticoids, hormonal compounds such as ocp, Bile acid sequestrants, sevelamer, orlistat ...)
History of liver disease (chronic liver disease), kidney (chronic renal failure with GFR ˂ 60 ml / min with persistent increase in parathyroid hormone), uncontrolled hypothyroidism, cystic fibrosis, primary hyperparathyroidism
History of neurological disorders
History of other autologous diseases
Patients with otitis media
Having chronic metabolic disorders that may affect vitamin D levels (malabsorption, gastrointestinal surgery, celiac disease, inflammatory bowel disease (IBD)).
Pregnant, breastfeeding
Reluctance to continue the project, at any time and for any reason during the study
Serious side effects during treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H81.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Meniere's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to receiving the usual Meniere treatment (betahistine) , Pearl Vitamin D supplement 50,000 units, one per week, after lunch and for 8 weeks will be prescribed.</i_keyword>
      <i_keyword>Control group: The placebo, which is exactly the same as the vitamin D supplement in shape and color, will be delivered once a week, after lunch, for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1. Comparison of the average severity of dizziness before and after the intervention in the group consuming vitamin D supplements. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: Visual Analogue Scale, Dizziness Handicap Inventory.</prim_outcome>
      <prim_outcome>2. Comparison of mean severity of vertigo before and after intervention in the placebo group. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: Visual Analogue Scale, Dizziness Handicap Inventory.</prim_outcome>
      <prim_outcome>3. Comparison of mean recurrence of vertigo before and after the intervention in the group consuming vitamin D supplements. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: Number of dizziness attacks per month.</prim_outcome>
      <prim_outcome>Comparison of mean recurrence of vertigo before and after intervention in the placebo group. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: Number of dizziness attacks per month.</prim_outcome>
      <prim_outcome>Comparison of the mean duration of dizziness before and after the intervention in the group consuming vitamin D supplements. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: The average duration of vertigo attacks per vertigo.</prim_outcome>
      <prim_outcome>6. Comparison of the mean duration of vertigo before and after the intervention in the placebo group. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: The average duration of vertigo attacks per vertigo.</prim_outcome>
      <prim_outcome>7. Determining the mean frequency × duration of vertigo in the group consuming vitamin D supplement and comparing it with the placebo group. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: The result of daily vertigo in each patient is calculated as the duration of vertigo × the recurrence of vertigo.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Comparison of the mean severity of tinnitus before and after the intervention in the group taking vitamin D supplements. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: Tinnitus Handicap Inventory.</sec_outcome>
      <sec_outcome>Comparison of the mean severity of tinnitus before and after the intervention in the placebo group. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: Tinnitus Handicap Inventory.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-25</approval_date>
        <contact_name>Working Group / Ethics Committee in Research Institute of Pharmaceutical Sciences, Tehran University</contact_name>
        <contact_address>pharmacy facualty, 16 azar street, keshavarz Ave tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
