<?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>IRCT20250502065563N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-03</date_registration>
      <primary_sponsor>Dezfoul University of Medical Sciences</primary_sponsor>
      <public_title>The effect of vitamin B1 on patients with hypothyroidism</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of vitamin B1 on thyroid hormones and lipid profile of patients  with hypothyroidism receiving levothyroxine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>49</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83549</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypothyroidism.</hc_freetext>
      <i_freetext>In the present before-and-after semi-experimental study, 49 patients with hypothyroidism between the ages of 30 and 50 years with TSH levels greater than 10 µIU/mL and T4 less than 4 ng/dL and serum Anti-TPO levels greater than 200 U/mL will be enrolled in the study with a diagnosis of hypothyroidism. Patients will receive the usual treatment for hypothyroidism, namely levothyroxine, and in the intervention group, in addition to levothyroxine, they will receive 300 mg of vitamin B1 tablet daily in the morning on an empty stomach and half to 1 hour before taking levothyroxine. The duration of the treatment period is 2 months. After the end of 2 months of treatment, blood samples will be taken from the patients and the variables of TSH, T4, Anti-TPO, TG, TC, LDL-C, HDL-C, and VLDL in the patients' serum will be measured. On the other hand, the LDL-C/HDL-C ratio and the atherogenic index will be calculated based on the formula (TG/HDL-C) log..</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 In accordance with the principles of publishing and writing articles for this category of studies, the results of this study can be published as an average in the resulting article and will not be published individually.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Akbar Oroojan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dezful, end of Azadegan Boulevard, next to the Traffic Department, New Medical School, Faculty of Education Vice Chancellor's Office</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6461653476</zip>
        <telephone>+98 61 4242 9533</telephone>
        <email>aliakbar_oroojan@yahoo.com</email>
        <affiliation>Dezfoul University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Akbar Oroojan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dezful, end of Azadegan Boulevard, next to the Traffic Department, New Medical School, Faculty of Education Vice Chancellor's Office</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6461653476</zip>
        <telephone>+98 61 4242 9533</telephone>
        <email>aliakbar_oroojan@yahoo.com</email>
        <affiliation>Dezfoul University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with hypothyroidism
The ages between 30 and 50 years old
TSH levels greater than 10 µIU/mL
T4 levels less than 4 ng/dL
Serum Anti-TPO levels greater than 200 U/mL</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of thyroid surgery
Thyroid malignancies
Hypothyroidism resulting from hyperthyroidism treatment
Other known autoimmune and rheumatic diseases
Renal failure and malabsorption
History of use of antithyroid drugs
History of use of cytotoxics
History of use of immunosuppressants
History of use of immunomodulators
History of use of glucocorticoids
History of use of amiodarone, lithium, interferon, radioiodine,
History of chemotherapy
History of use of supplements containing vitamin B1
pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other hypothyroidism</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the present before-and-after semi-experimental study, 49 patients with hypothyroidism between the ages of 30 and 50 years with TSH levels greater than 10 µIU/mL and T4 less than 4 ng/dL and serum Anti-TPO levels greater than 200 U/mL will be enrolled in the study with a diagnosis of hypothyroidism. Patients will receive the usual treatment for hypothyroidism, namely levothyroxine, and in the intervention group, in addition to levothyroxine, they will receive 300 mg of vitamin B1 tablet daily in the morning on an empty stomach and half to 1 hour before taking levothyroxine. The duration of the treatment period is 2 months. After the end of 2 months of treatment, blood samples will be taken from the patients and the variables of TSH, T4, Anti-TPO, TG, TC, LDL-C, HDL-C, and VLDL in the patients' serum will be measured. On the other hand, the LDL-C/HDL-C ratio and the atherogenic index will be calculated based on the formula (TG/HDL-C) log.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Thyroxine hormone (T4). Timepoint: Before the start of the study and 1 month and 2 months after starting to take vitamin B1 tablets. Method of measurement: Blood collection from the patient and serum separation.</prim_outcome>
      <prim_outcome>Thyroid-stimulating hormone (TSH). Timepoint: Before the start of the study and 1 month and 2 months after starting to take vitamin B1 tablets. Method of measurement: Blood collection from the patient and serum separation.</prim_outcome>
      <prim_outcome>Serum Anti-TPO. Timepoint: Before the start of the study and 1 month and 2 months after starting to take vitamin B1 tablets. Method of measurement: Blood collection from the patient and serum separation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum total cholesterol (TC). Timepoint: Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets. Method of measurement: Blood collection and serum separation from the patient.</sec_outcome>
      <sec_outcome>Serum LDL-C. Timepoint: Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets. Method of measurement: Blood collection and serum separation from the patient.</sec_outcome>
      <sec_outcome>Serum HDL-C. Timepoint: Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets. Method of measurement: Blood collection and serum separation from the patient.</sec_outcome>
      <sec_outcome>LDL-C to HDL-C ratio. Timepoint: Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets. Method of measurement: Blood collection and serum separation from the patient.</sec_outcome>
      <sec_outcome>Serum triglycerides (TG). Timepoint: Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets. Method of measurement: Blood collection and serum separation from the patient.</sec_outcome>
      <sec_outcome>Serum VLDL. Timepoint: Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets. Method of measurement: Blood collection and serum separation from the patient.</sec_outcome>
      <sec_outcome>Atherogenic index. Timepoint: Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets. Method of measurement: Blood collection and serum separation from the patient.</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>Dezfoul University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-13</approval_date>
        <contact_name>Research Ethics Committees of Dezful University of Medical Sciences</contact_name>
        <contact_address>Dezful, end of Azadegan Boulevard, next to the Traffic Department Dezful Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
