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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
none |
Patients |
vitiligo, |
|
Intervention / Comparator Agent
|
|
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. |