<?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>IRCT20230123057193N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-17</date_registration>
      <primary_sponsor>Research assistant of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of vitamin C supplementation on oxidative stress indices and skin repigmentation of patient with vitiligo</public_title>
      <acronym></acronym>
      <scientific_title>The effect of vitamin C supplementation on oxidative stress indices and skin repigmentation of patient with vitiligo</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68238</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study subjects will be block-blocked based on gender and receiving or not receiving phototherapy, and then they will be randomly divided into two intervention groups with vitamin C and placebo. Random allocation: RAS) (size 4) were assigned to intervention and placebo groups, and patients were placed in blocks of 4 based on receiving or not receiving phototherapy and gender.
In this study, the participants are randomly placed in two intervention and placebo groups so that researchers can compare different treatments. Researchers and participants cannot arbitrarily play a role in assigning people to groups. Random assignment of people to the intervention or placebo group will be done by an experienced expert, Blinding description: All subjects and researchers and healthcare personnel who are responsible for the care of patients will be unaware of the existing grouping until the end of the study; In such a way, the researcher and the person who takes the sample, like the study participants, are unaware of which patient will receive the vitamin pill or the placebo. Patients are also unaware of the type of pill received. Drugs and placebos are coded by a person who is completely unaware of the study process, and this code is placed in an envelope that indicates whether it is a drug or a placebo code. One group will receive drug A and one group will receive drug B.
  Also, pills containing vitamin C and placebo, which have the same color, smell, and size as the vitamin pill, will be given to the study subjects every 4 weeks by another person who has no knowledge of the research process. Hence, this study will be a double-blind study.
Placebo tablets contain starch and are completely similar to vitamin C tablets in terms of color, appearance and smell. Placebo tablets are also prepared by the same company that manufactures vitamin C.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Vitiligo.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group will receive daily 1 tablets of vitamin C 1000 mg with water for 8 weeks. Vitamin C tablets will be purchased from the Gol-darou Company with C Fix brand. All the patients will be monitored for consumption of tablets by daily checklists and recall messages. Intervention 2: The control group will receive daily 1 tablets of placebo with water for 8 weeks. placebo tablets will be purchased from the Gol-darou Company. All the patients will be monitored for consumption of tablets by daily checklists and recall messages.</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 Patient information will remain confidential. There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soraiya Ebrahimpour-koujan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran-Vahdat-Islami Street-Vahdat-Islami Square-Razi Dead End-Razi Skin Specialist Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۹۹۶۶۳۹۱۱</zip>
        <telephone>+98 21 5563 0553</telephone>
        <email>nutri.seam1@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soraiya Ebrahimpour-koujan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran-Vahdat-Islami Street-Vahdat-Islami Square-Razi Dead End-Razi Skin Specialist Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۹۹۶۶۳۹۱۱</zip>
        <telephone>+98 21 5563 0553</telephone>
        <email>nutri.seam1@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of vitiligo by a dermatologist, without gender restrictions
Newly diagnosed vitiligo patient (under one month) or less than 10 phototherapy sessions
Adults 20-60 years old</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Being pregnant or breastfeeding
Underlying diseases, including malignancy, history of kidney stones, other chronic and inflammatory diseases except vitiligo
Taking antibiotics, antivirals and antifungals
Use of vitamin C supplements and antioxidants in the last 3 months
Any history of alcohol and tobacco use</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>L80- Diseases of the skin and subcutaneous tissue.</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 will receive daily 1 tablets of vitamin C 1000 mg with water for 8 weeks. Vitamin C tablets will be purchased from the Gol-darou Company with C Fix brand. All the patients will be monitored for consumption of tablets by daily checklists and recall messages</i_keyword>
      <i_keyword>The control group will receive daily 1 tablets of placebo with water for 8 weeks. placebo tablets will be purchased from the Gol-darou Company. All the patients will be monitored for consumption of tablets by daily checklists and recall messages</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Catalase. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Regimentation. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: vitiligo area scoring index (VASI) score.</sec_outcome>
      <sec_outcome>Superoxide dismutase. Timepoint: ابتدای مطالعه (قبل از شروع مداخله) و 8 هفته پس از مداخله. Method of measurement: ELISA assay.</sec_outcome>
      <sec_outcome>Total oxidant status. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.</sec_outcome>
      <sec_outcome>Total antioxidant capacity. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.</sec_outcome>
      <sec_outcome>Malondialdehyde. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.</sec_outcome>
      <sec_outcome>Glutathione peroxidase. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.</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>Research assistant of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-07</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz blv., Ghods st. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
