| CTRI Number |
CTRI/2024/02/063073 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see how thyroid replacement affects lipid profile,anti TPO-antibody,hs-CRP levels in patients who are newly diagnosed cases of hypothyroidism |
|
Scientific Title of Study
|
Effect of levothyroxine replacement on lipid profile,anti TPO-antibody,hs-CRP levels in newly diagnosed cases of hypothyroidism |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rucha Sawant |
| Designation |
junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Medicine, third floor, Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru medical college,
Sawangi,
Wardha.
Wardha
MAHARASHTRA
442004
India |
| Phone |
8554944433 |
| Fax |
|
| Email |
ruchasawant26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sourya Acharya |
| Designation |
PhD, Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Medicine, Datta Meghe Institute of Higher Education and Research(Deemed to be University), Jawaharlal Nehru Medical College, Sawangi(Meghe), Wardha, Maharashtra – 442001
Wardha
MAHARASHTRA
442004
India |
| Phone |
9511840372 |
| Fax |
|
| Email |
souryaacharya74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rucha Sawant |
| Designation |
junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Medicine, third floor, Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru medical college,
Sawangi,
Wardha.
Wardha
MAHARASHTRA
442004
India |
| Phone |
8554944433 |
| Fax |
|
| Email |
ruchasawant26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of medicine, Datta Meghe Institute of Higher education and Research, Sawangi (Meghe),
Wardha |
|
|
Primary Sponsor
|
| Name |
Rucha Sawant |
| Address |
Department of medicine, Datta Meghe Institute of Higher Education and Research , sawangi wardha |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rucha Sawant |
Acharya Vinoba Bhave Rural Hospital |
Department of General Medicine, third floor, Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru medical college, Sawangi, Wardha.
Wardha
MAHARASHTRA |
8554944433
ruchasawant26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E039||Hypothyroidism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
levothyroxine |
Tablet Levothyroxine 50mcg OD for hypothyroidism and Tablet Levothyroxine 25mcg OD for subclinical hypothyroidism will be given supplemented and effects will be observed before and after 2 months of treatment |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical features suggestive of hypothyroidism and diagnosis made as per report of thyroid profile.
|
|
| ExclusionCriteria |
| Details |
1. Patients who were not on any thyroid supplement.
2. Patients on antithyroid drugs( carbimazole, methimazole, propylthiouracil)
3. DM (Diabetes mellitus).
4. CAD (Coronary artery disease).
5. Critically ill patients.
6. CKD( chronic kidney disease)
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Lipid Profile Improvement: The study will evaluate whether Levothyroxine treatment leads to significant changes in these lipid parameters, potentially demonstrating improvements in cardiovascular risk factors.
2. Anti-TPO Antibody Levels: This assessment aims to determine whether Levothyroxine replacement therapy has any discernible effect on the autoimmune component of hypothyroidism by monitoring the Anti-TPO Ab levels over the course of the study.
3. hsCRP Levels: Elevated hsCRP is indicative of increased inflammation and is associated with various cardiovascular risks. The study aims to discern whether Levothyroxine treatment influences hsCRP levels, potentially indicating a reduction in inflammation and related risks.
|
the data will be assessed between the time period of 1.5 years,i.e:01/09/2022 to 31/03/2024 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| as per the literature review available the correlation with levels of lipid Profile, anti-TPO antibody, and hsCRP with the treatment of newly diagnosed hypoparathyroidism will be positive |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Hypothyroidism is a
common endocrine disorder with systemic implications, including adverse effects
on lipid metabolism, immune function, and inflammation. This research proposal
outlines a study evaluating the impact of Levothyroxine replacement therapy on
key clinical parameters in newly diagnosed cases of hypothyroidism.
Methods: The study will be
conducted at Acharya Vinoba Bhave Rural Hospital for two years, from July 2022
to July 2024, employing a cross-sectional study design. Eligible participants
will be identified based on clinical features and confirmed through thyroid
profile reports. Exclusion criteria will be applied to ensure the homogeneity
of the study population.
Data Collection: Data will be collected
through comprehensive assessments, including history taking, clinical
examination, and laboratory investigations. Laboratory tests will encompass
lipid profiles, thyroid function tests, high-sensitivity C-Reactive Protein
(hs-CRP) levels, and Anti-Thyroid Peroxidase Antibody (Anti-TPO Ab) levels.
Excepted result: In this study, we
anticipate that Levothyroxine replacement therapy in newly diagnosed cases of
hypothyroidism will result in favorable changes in crucial health markers. We
expect to observe improvements in the lipid profile, with reductions in total
cholesterol and LDL cholesterol and an increase in beneficial HDL cholesterol,
indicating a positive impact on cardiovascular risk factors. Additionally, we
anticipate a decrease in anti-thyroid peroxidase Antibody (Anti-TPO Ab) levels,
suggesting a potential amelioration of the autoimmune aspect of hypothyroidism.
Furthermore, we expect a reduction in high-sensitivity C-Reactive Protein
(hs-CRP) levels, indicating a potential reduction in inflammation and
associated cardiovascular risks. |