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CTRI Number  CTRI/2024/03/063798 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 06/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Disease related to iodine salt lack among people living in Jharkhand 
Scientific Title of Study   Correlation between serum iron and inflammatory markers with hypothyroidism and its associated metabolic comorbidities 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monit sundriyal 
Designation  Tutor 
Affiliation  Manipal Tata medical college 
Address  Second floor, Left Wing, Room number246, administration building, Department of Biochemistry, Manipal Tata medical college, Baridih Kadani Road , Jamshedpur , Jharkhand

Purbi Singhbhum
JHARKHAND
831017
India 
Phone  7830956045  
Fax    
Email  monit.sundriyal@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Takkella Nagamma 
Designation  Assistant Professor 
Affiliation  Manipal Tata Medical College 
Address  Second floor, Left Wing, Room number 246, administration building, Department of Biochemistry, Manipal Tata medical college, Baridih Kadani Road , Jamshedpur , Jharkhand

Purbi Singhbhum
JHARKHAND
831017
India 
Phone  8105005338  
Fax    
Email  takkella.nagamma@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Monit sundriyal 
Designation  Tutor 
Affiliation  Manipal Tata medical college 
Address  Second floor, Left Wing, Room number 246, administration building, Department of Biochemistry, Manipal Tata medical college, Baridih Kadani Road , Jamshedpur , Jharkhand

Purbi Singhbhum
JHARKHAND
831017
India 
Phone  7830956045  
Fax    
Email  monit.sundriyal@manipal.edu  
 
Source of Monetary or Material Support  
Dept. of Biochemistry, Second floor left wing, room no 246, Department of Biochemistry, Manipal Tata Medical college,Baridih , Kadani road, East singhbhum , Jamshedpur, Jharkhand 
 
Primary Sponsor  
Name  Monit sundriyal 
Address  Second floor left wing, room no 246, Department of Biochemistry, Manipal Tata Medical college,Baridih , Kadani road, East singhbhum , Jamshedpur, Jharkhand 
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 Takella Nagamma  Manipal Tata medical college  second floor,left wing,room no 246, Department of Biochemistry,Manipal Tata medical college,Kadani Road East singhbhum ,Jamshedpur ,Jharkhand
Purbi Singhbhum
JHARKHAND 		 8105005338

takkella.nagamma@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manipal Tata Medical college Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E039||Hypothyroidism, unspecified, (2) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  i)Age group between (18 - 70 years) will be included in the study.
ii)Patients diagnosed with overt, subclinical hypothyroidism with or without CVD or/CKD metabolic comorbidities.
iii) Controls with euthyroidism without CVD, CKD or autoimmune disorder, inflammatory diseases like (Hashimoto’s thyroiditis, Rheumatoid arthritis and Lupus) immune-compromised will be taken in the study.
 
 
ExclusionCriteria 
Details  i) Study participants less than 18 years & women with pregnancy will not be included.
ii)The study will not include patients on medication with antithyroid drugs, lipid-lowering drugs, antihypertensives, or any other steroids for inflammatory diseases.
iii) Patients and healthy controls on antioxidant supplementation or other supplements that affect oxidative stress will be excluded from the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)BMI, lipid profile, and inflammatory marker levels may elevate in subclinical hypothyroidism, hypothyroidism, and associated disorders.
2)Smoking and alcohol may increase the lipid profile & inflammatory marker levels in hypothyroidism patients and associated disorders.

3)Total blood cell counts and iron profile levels may alter in hypothyroidism.
 		 1)BMI, lipid profile, and inflammatory marker levels may elevate in subclinical hypothyroidism, hypothyroidism, and associated disorders. (6 months)
2)Smoking and alcohol may increase the lipid profile & inflammatory marker levels in hypothyroidism patients and associated disorders.(6 months)

3)Total blood cell counts and iron profile levels may alter in hypothyroidism. (6 months)
 
 
Secondary Outcome  
Outcome  TimePoints 
Total blood cell count and iron profile levels may alter in hypothyroidism.
 		 6 months 
 
Target Sample Size   Total Sample Size="482"
Sample Size from India="482" 
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)   14/03/2024 
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="3"
Months="8"
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  
Thyroid disease is one of the most prevalent Endocrinological Disorders in India, and around the world, it affects more than 200 million people. The incidence of Thyroid gland disorders is 10 - 15% more advanced in the female population in comparison with the male population; the Prevalence of thyroid diseases is around 15 - 25% in various regions of India, while developed countries have a prevalence of about 4-9% only. Jharkhand which is an iodine deficient state, the proportion of thyroid disorder is 6% population affected by overt hypothyroidism, while 13.7% affected by subclinical hypothyroidism (SCH), and 6.3% population affected by hyperthyroidism and its other types. Jharkhand state is considered an iodine-deficient belt, due to which thyroid disorders are more prevalent. Anaemia cases are commonly present due to low socio-economic status and low nutritional diet in the Jharkhand population.  Hypothyroidism, if not treated, can become a risk factor for anemia and may lead to developing cardiovascular disorders and chronic kidney diseases.  The aim of the study will be: To Evaluate the correlation between Iron status, dyslipidemia, Oxidative Stress, & inflammatory markers on hypothyroidism and its associated disorders. The study will be a case-control study, Results will be reported as a mean and standard mean error with the help of statistical software GraphPad Prism 5, Pearson correlation method will be used to find the correlation between biochemical parameters and their association disorders.
 
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