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CTRI Number  CTRI/2018/04/013391 [Registered on: 20/04/2018] Trial Registered Retrospectively
Last Modified On: 18/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   correlation between vitiligo and thyroid diseases 
Scientific Title of Study   Vitiligo and autoimmune thyroid disorders 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JIMISH DEEPAK BAGADIA 
Designation  Assistant professor 
Affiliation  K.J.Somaiya Medical college & Research centre 
Address  Department of Dermatology, 6th floor, college bldg, KJ Somaiya Medical college & Research centre, Everard nagar, Sion

Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  9702713534  
Fax    
Email  jimishb@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shital Poojary 
Designation  Professor & Department head 
Affiliation  K.J.Somaiya Medical college & Research centre 
Address  Department of dermatology, OPD-26, 6th floor, K.J.Somaiya Medical college & Research centre, Everard nagar, Sion

Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  9820601511  
Fax    
Email  spoojary2004@gmail.com  
 
Details of Contact Person
Public Query
 
Name  JIMISH DEEPAK BAGADIA 
Designation  Assistant professor 
Affiliation  K.J.Somaiya Medical college & Research centre 
Address  Department of Dermatology, 6th floor, college bldg, KJ Somaiya Medical college & Research centre, Everard nagar, Sion

Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  9702713534  
Fax    
Email  jimishb@gmail.com  
 
Source of Monetary or Material Support  
KJ Somaiya Medical college & Research centre 
 
Primary Sponsor  
Name  Dr Jimish Bagadia 
Address  Department of Dermatology, 6th floor, college bldg, KJ Somaiya Medical college & Research centre, Everard nagar, Sion 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jimish Deepak Bagadia  KJ Somaiya Medical college and Research centre  OPD-26, department of dermatology, 6th floor, college building, KJ Somaiya medical college and Research centre, Everard nagar, Sion (E), Mumbai-400022
Mumbai (Suburban)
MAHARASHTRA 
9702713534

jimishb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KJ Somaiya Medical college and hospital, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  none 
Patients  vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  all clinically diagnosed vitiligo patients and apparently healthy controls which were age and sex matched 
 
ExclusionCriteria 
Details  1. those who did not consent to be a part of the study
2. those who were previously diagnosed with thyroid disease, and were taking medicines for the same or had undergone any thyroid surgery
3. those who were on oral immunosuppressants in the last 1 month 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
thyroid dysfunction in vitiligo patients and controls  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
statistical significant correlation between vitiligo and thyroid dysfunction when compared to control  2 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2012 
Date of Study Completion (India) 28/02/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Background: Vitiligo is a commonly acquired pigmentary disorder, in which there is loss or destruction of melanocytes leading to depigmentation. The exact etiology is unknown; it is believed to be multifactorial with various theories believed to play a role, the important ones being the autoimmune hypothesis and the oxidative stress theory. The association of vitiligo with other autoimmune disorders, especially thyroid diseases, is known.

Aims & Objectives: To determine if a statistically significant correlation exists between vitiligo and autoimmune thyroid disorders.

Methods: A case-control study was carried out on 64 vitiligo patients (41 females and 23 males) and 64 age and sex-matched healthy volunteers. Patients with known thyroid disease, having history of thyroid surgery and those receiving thyroid medications and immunosuppressants were not included in the study. Serum T3, T4 and TSH levels along with anti-TPO antibodies were measured in all the subjects.

Results: There were 13 cases (20.3%) with thyroid abnormalities in the study group compared to 4 cases (6.25%) in the control group. This difference was statistically significant (p = 0.03). Also, anti-TPO positivity was seen in 12 cases (18.8%) in the study group, while it was present in only 3 cases in the control group (4.7%) resulting in a statistically significant difference (p = 0.025). However, TSH abnormalities between the 2 groups did not vary significantly. Also, no statistical significance was found in thyroid abnormalities between the children of the 2 groups. Anti-TPO positivity did not vary with disease severity and activity of vitiligo.

Conclusions: It is recommended that screening of otherwise asymptomatic vitiligo adults should be carried out on an individual basis, based on factors such as positive family history, female gender and age group of 20-40 years for a more productive and cost-effective outcome. Also, it might not be fruitful to screen vitiligo children for thyroid function. Similar larger studies are required to establish acceptable guidelines on full scale regular screening of vitiligo patients for thyroid function, especially in resource-limited settings.

 
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