| CTRI Number |
CTRI/2025/02/080166 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to observe the prevalence of thyroid dysfunction in patients with Chronic Kidney Disease with participants being diagnosed cases of chronic kidney disease and main outcome of study being the relationship between chronic kidney disease and thyroid dysfunction |
|
Scientific Title of Study
|
An Observational Cross Sectional Study on the prevalence of thyroid dysfunction in patients with chronic kidney disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KUSH THAKER |
| Designation |
Junior Resident |
| Affiliation |
Dr D Y Patil Medical College , Navi Mumbai |
| Address |
Department of General Medicine Dr D Y Patil Medical College , Navi Mumbai
Thane
MAHARASHTRA
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
9769153420 |
| Fax |
|
| Email |
kushthaker19.1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arundhati Barua |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Medical College , Navi Mumbai |
| Address |
Department of General Medicine Dr D Y Patil Medical College , Navi Mumbai
Thane
MAHARASHTRA
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
9819192212 |
| Fax |
|
| Email |
arundhatibb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KUSH THAKER |
| Designation |
Junior Resident |
| Affiliation |
Dr D Y Patil Medical College , Navi Mumbai |
| Address |
Department of General Medicine Dr D Y Patil Medical College , Navi Mumbai
Thane
MAHARASHTRA
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
09769153420 |
| Fax |
|
| Email |
kushthaker19.1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Medical College and Hospital , Nerul , Navi Mumbai - 400706 , Maharashtra , India - |
|
|
Primary Sponsor
|
| Name |
Kush Thaker |
| Address |
Junior Resident
Department of General Medicine
Dr. DY Patil Medical College
Navi Mumbai - 400706 |
| Type of Sponsor |
Other [Primary Investigator] |
|
|
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 |
| Kush Thaker |
Dr DY Patil Hospital |
Department of General Medicine
Navi Mumbai
Thane
MAHARASHTRA
400706
India
Thane
MAHARASHTRA |
09769153420
kushthaker19.1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research , Dr DY Patil Medical College , Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients of Chronic Kidney Disease , aged 12 and above , undergoing or not undergoing dialysis |
|
| ExclusionCriteria |
| Details |
Patients not consenting to enroll in the study.
Patients who are cases of Acute Kidney Injury.
Patients with any autoimmune condition.
Patients on antipsychotic medications.
Patients with family history of hypothyroidism. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Free T3
Free T4
Thyroid Stimulating Hormone |
Baseline
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Co relation between Thyroid Dysfunction and Chronic Kidney Disease |
Baseline
1 year |
|
|
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)
|
20/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is an observational cross sectional study of prevalence of thyroid dysfunction in patients with chronic kidney disease and the relationship between thyroid dysfunction and chronic kidney disease and its outcomes and inter relationships. |