<?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>IRCT20260622069921N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-28</date_registration>
      <primary_sponsor>CMH Hyderabad</primary_sponsor>
      <public_title>Effect of levothyroxine therapy on serum lipid profile in patients with subclinical hypothyroidism</public_title>
      <acronym></acronym>
      <scientific_title>Changes in serum lipid profile following six months of levothyroxine therapy in patients with subclinical hypothyroidism: a quasi-experimental study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-03-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91093</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Sub-clinical hypothyroidism (SCH) refers to the condition in which there is increase in the levels of serum TSH with normal T3 and T4 levels. While the condition does not manifest clinically in majority of the cases, it is associated with weight gain, hormonal disturbances, insulin resistance, dyslipidemia, and increased incidence of cardiac complications..</hc_freetext>
      <i_freetext>Intervention group:  All enrolled participants will receive levothyroxine sodium tablets (Thyroxine tablets - Getz Pharma) administered at an initial dose of 1.6 mcg/kg/day, based body weight taken once daily in the morning on an empty stomach, at least 30-60 mins before breakfast with water. Treatment will continue for six months. Compliance will be assessed during follow up visits..</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 Limitations in participant consent, data sharing policy of institute and confidentiality of study participants.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Brig. Asad Mahmood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CMH Road, Saddar, Cantonment, CMH Hyderabad</address>
        <city>Hyderabad</city>
        <country1>Pakistan</country1>
        <zip>71110</zip>
        <telephone>+92 333 9649234</telephone>
        <email>asad1620@gmail.com</email>
        <affiliation>CMH Hyderabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Muhammad Ali Aslam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CMH Road, Saddar, Cantonement, CMH Hyderabad</address>
        <city>Hyderabad</city>
        <country1>Pakistan</country1>
        <zip>71110</zip>
        <telephone>+92 341 0441717</telephone>
        <email>aliaslam187@gmail.com</email>
        <affiliation>CMH Hyderabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>diagnosis of subclinical hypothyroidism
levothyroxine therapy planned for six months
18-65 years of age</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients already on thyroid replacement therapy
Overt Hypothyroidism or hyperthyroidism
Pregnancy, lactation
Use of medications known to significantly affect thyroid function or lipid metabolism e.g. amiodrone, statins</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Subclinical iodine-deficiency hypothyroidism</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  All enrolled participants will receive levothyroxine sodium tablets (Thyroxine tablets - Getz Pharma) administered at an initial dose of 1.6 mcg/kg/day, based body weight taken once daily in the morning on an empty stomach, at least 30-60 mins before breakfast with water. Treatment will continue for six months. Compliance will be assessed during follow up visits.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lipid profile. Timepoint: Change in serum lipid levels at baseline (before initiation of levothyroxine therapy), 12 weeks after initiation of therapy, 24 weeks after initiation of therapy. Method of measurement: Laboratory investigations - complete blood count, thyroid profile (TSH, T3, T4), and fasting lipid profile (total cholesterol, LDL, HDL, triglycerides).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Secondary variables studied were time to achieve euthyroid status (based on serum TSH levels). Timepoint: Before intervention, 12 weeks after initiation of levothyroxine therapy, 24 weeks after initiation of levothyroxine therapy. Method of measurement: Laboratory investigations including complete blood count, thyroid profile (TSH, T3, T4), and fasting lipid profile (total cholesterol, LDL, HDL, triglycerides).</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>CMH Hyderabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-26</approval_date>
        <contact_name>The Ethical Committee/Institutional Review Board of CMH Hyderabad</contact_name>
        <contact_address>CMH Road, Saddar, Cantonment, CMH Hyderabad Hyderabad Sindh Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
