| CTRI Number |
CTRI/2024/07/070095 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
IMPACT OF CHRONIC KIDNEY DISEASE ON THYROID HORMONE LEVELS |
|
Scientific Title of Study
|
Study of thyroid profile in patients with chronic kidney disease in tertiary care center |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushrut Gupta |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9557612010 |
| Fax |
|
| Email |
drsushrutguptamd1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Pasari |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422164630 |
| Fax |
|
| Email |
dramit2811@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Pasari |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422164630 |
| Fax |
|
| Email |
dramit2811@gmail.com |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU MEDICAL COLLEGE,Datta Meghe Institute of Higher Education and Research,SAWANGI(MEGHE),WARDHA,MAHARASHTRA,INDIA |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Sushrut Gupta |
Datta Meghe Institute of Higher Education and Research |
DEPARTMENT OF NEPHROLOGY
Wardha
MAHARASHTRA |
9557612010
drsushrutguptamd1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences Sawangi (Meghe) Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients of Chronic Kidney Disease above the age of 18 years. Patients voluntarily willing to give informed consent will be taken for this study.
|
|
| ExclusionCriteria |
| Details |
Family history of thyroid disorder. Known case of thyroid disorders whether having medication or not. History of any surgery or any radiological intervention to thyroid gland. Patients on drugs altering thyroid profile such as amiodarone, phenytoin, oestrogen pills and iodine containing drugs. Pregnant females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study could be defined as the prevalence of thyroid function abnormalities (such as subclinical hypothyroidism, overt hypothyroidism, hyperthyroidism, and low T3 syndrome) in patients with chronic kidney disease (CKD), categorized according to different stages. |
BASELINE AND 12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study aims to examine thyroid function in chronic kidney disease (CKD) patients across different stages and assess the prevalence of thyroid abnormalities. Secondary outcomes include investigating correlations between thyroid function and CKD stages, as well as changes in quality of life, estimated glomerular filtration rate (eGFR), and Body Mass Index (BMI) after 3 months of treatment in non-dialysis CKD patients. |
1 Month |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
01/08/2024 |
| 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
|
The study proposes to investigate the thyroid profile in patients with chronic kidney disease (CKD) in a tertiary care center. The rationale underscores the importance of understanding the relationship between thyroid hormones and CKD due to overlapping symptoms and potential treatment implications. The objectives include evaluating thyroid function, correlating abnormalities with CKD stages, assessing quality of life, and monitoring changes after treatment. Ethical approval and informed consent will be obtained, with data collected through patient history, examination, and laboratory tests. Statistical analysis will be conducted using SPSS software. The study aims to contribute valuable insights into thyroid function in CKD patients, potentially informing clinical management strategies. |