1. Home
  2. Approved trials
  3. » فارسی

Changes in serum lipid profile following six months of levothyroxine therapy in patients with subclinical hypothyroidism: a quasi-experimental study

Protocol summary

Study aim
The aim of this study is to evaluate the lipid profile level changes assessed by total serum cholesterol (TC), serum low density lipoproteins (LDLs), serum triglycerides (TGs) and serum high density lipoproteins (HDLs) after six months of levothyroxine therapy in patients with presenting with sub-clinical hypothyroidism.
Design
Pragmatic research, quasi experimental study, carried out at the Department of Medicine, Combined Military Hospital, Hyderabad from August 2025 – January 2026
Settings and conduct
After approval from the Institutional Ethical Review Committee, CMH Hyderabad, the study was conducted in the institute, ensuring strict confidentiality and data protection according to institutional and international guidelines. Simple random sampling was used to recruit a total of 90 adult patients aged 18–65 years diagnosed with mild SCH (sub-clinical hypothyroidism) (TSH 4.49–10 mIU/L) or moderate SCH (TSH >10 mIU/L) with normal T3 and T4 levels. They were screened through laboratory-verified thyroid profiles.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients aged 18-65 years of age diagnosed with sub-clinical hypothyroidism (mild and moderate) as per the WHO definition criteria furnished in the methodology and planned for levothyroxine therapy for six months. Exclusion criteria: patients already on thyroid replacement therapy, Overt hypothyroidism or Hyperthyroidism, Pregnancy or lactation, use of medications significantly known to affect thyroid function or lipid metabolism ( e.g amiodarone, statins)
Intervention groups
All patients received the same levothyroxine regimen of 1.6 mcg/kg/day.
Main outcome variables
Primary variables studied were mean change in serum lipid levels assessed by total serum cholesterol, serum low density lipoproteins, serum triglycerides and serum high density lipoproteins.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260622069921N1
Registration date: 2026-06-28, 1405/04/07
Registration timing: retrospective

Last update: 2026-06-28, 1405/04/07
Update count: 0
Registration date
2026-06-28, 1405/04/07
Registrant information
Name
Muhammad Ali Aslam
Name of organization / entity
Armed forces post graduate medical institute Rawalpindi
Country
Pakistan
Phone
+92 341 0441717
Email address
aliaslam187@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-26, 1404/01/06
Expected recruitment end date
2026-01-01, 1404/10/11
Actual recruitment start date
2025-03-27, 1404/01/07
Actual recruitment end date
2026-01-02, 1404/10/12
Trial completion date
2026-01-05, 1404/10/15
Scientific title
Changes in serum lipid profile following six months of levothyroxine therapy in patients with subclinical hypothyroidism: a quasi-experimental study
Public title
Effect of levothyroxine therapy on serum lipid profile in patients with subclinical hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of subclinical hypothyroidism levothyroxine therapy planned for six months 18-65 years of age
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 112
More than 1 sample in each individual
Number of samples in each individual: 112
Simple random sampling was used to recruit patients diagnosed with Subclinical Hypothyroidism.
Actual sample size reached: 90
More than 1 sample in each individual
Actual sample size in each individual: 90
Simple random sampling was used to recruit a total of 90 adult patients aged 18–65 years diagnosed with mild SCH (sub-clinical hypothyroidism) (TSH 4.49–10 mIU/L) or moderate SCH (TSH >10 mIU/L) with normal T3 and T4 levels
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethical Committee/Institutional Review Board of CMH Hyderabad
Street address
CMH Road, Saddar, Cantonment, CMH Hyderabad
City
Hyderabad
Postal code
71110
Approval date
2025-03-26, 1404/01/06
Ethics committee reference number
No/11105/Estb

Health conditions studied

1

Description of health condition studied
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.
ICD-10 code
E02
ICD-10 code description
Subclinical iodine-deficiency hypothyroidism

Primary outcomes

1

Description
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)

Secondary outcomes

1

Description
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).

Intervention groups

1

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
CMH Hyderabad, Hyderabad Cantonment
Full name of responsible person
Brig. Asad Mahmood
Street address
CMH Road, Saddar, Cantonment, CMH Hyderabad
City
Hyderabad
Postal code
71110
Phone
+92 341 0441717
Email
aliaslam187@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
CMH Hyderabad
Full name of responsible person
Brig. Asad Mahmood
Street address
CMH Road, Saddar, Cantonment, CMH Hyderabad
City
Hyderabad
Postal code
71110
Phone
+92 333 9649234
Email
asad1620@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CMH Hyderabad
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
CMH Hyderabad
Full name of responsible person
Brig. Asad Mahmood
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
CMH Road, Saddar, Cantonment, CMH Hyderabad
City
Hyderabad
Province
Sindh
Postal code
71110
Phone
+92 333 9649234
Email
asad1620@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
CMH Hyderabad
Full name of responsible person
Muhammad Ali Aslam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
CMH Road, Saddar, Cantonement, CMH Hyderabad
City
Hyderabad
Province
Sindh
Postal code
71110
Phone
+92 341 0441717
Email
aliaslam187@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Independent Researcher
Full name of responsible person
Dania Mudassar
Position
General Dentist
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
CMH Road, Saddar, Cantonment
City
Hyderabad
Province
Sindh
Postal code
71110
Phone
+92 341 5072055
Email
dania.mudassar@outlook.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Limitations in participant consent, data sharing policy of institute and confidentiality of study participants.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...