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CTRI Number  CTRI/2017/05/008596 [Registered on: 19/05/2017] Trial Registered Prospectively
Last Modified On: 02/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Vitamin D supplementation in improving Thyroid disease of mild variety 
Scientific Title of Study   Impact of Vitamin D Supplementation on Thyroid Function in Subclinical Autoimmune Hypothyroidism - A Randomized Double Blind Placebo Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
V1.0/05/2017/097  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Debarati Bhar 
Designation  Post doctorate Trainee 
Affiliation  Institute of Postgraduate Medical Education and Research and SSKM Hospital  
Address  Department of Endocrinology Room 9A 4th Floor Ronald Ross Building Institute of Postgraduate Medical Education and Research and SSKM Hospital 244 A J C Bose Road Kolkata 20

Kolkata
WEST BENGAL
700020
India 
Phone  9433111811  
Fax  03322236558  
Email  debaratibhar1234@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Satinath Mukhopadhyay 
Designation  Professor 
Affiliation  Institute of Postgraduate Medical Education and Research and SSKM Hospital  
Address  Department of Endocrinology Room 9A 4th Floor Ronald Ross Building Institute of Postgraduate Medical Education and Research and SSKM Hospital 244 A J C Bose Road Kolkata 20

Kolkata
WEST BENGAL
700020
India 
Phone    
Fax    
Email  satinath.mukhopadhyay@gmail.com  
 
Details of Contact Person
Public Query  
Name  Debarati Bhar 
Designation  Post doctorate Trainee 
Affiliation  Institute of Postgraduate Medical Education and Research and SSKM Hospital  
Address  Department of Endocrinology Room 9A 4th Floor Ronald Ross Building Institute of Postgraduate Medical Education and Research and SSKM Hospital 244 A J C Bose Road Kolkata 20

Kolkata
WEST BENGAL
700020
India 
Phone  9433111811  
Fax  03322236558  
Email  debaratibhar1234@gmail.com  
 
Source of Monetary or Material Support  
244 AJC Bose Road Institute of Postgraduate Medical Education and Research and SSKM Hospital Kolkata Pin 700020 
 
Primary Sponsor  
Name  Institute of Postgraduate Medical Education and Research and SSKM Hospital  
Address  244 A J C Bose Road Kolkata 20 
Type of Sponsor  Research institution and hospital 
 
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 
DEBARATI BHAR  Institute of Postgraduate Medical Education and Research and SSKM Hospital   Room No 9A Ronald Ross Building 4th Floor Department of Endocrinology 244 A J C Bose Road Kolkata 20
Kolkata
WEST BENGAL 		 9433111811
03322236558
debaratibhar1234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E063||Autoimmune thyroiditis, (2) ICD-10 Condition: E063||Autoimmune thyroiditis, Subclinical Cases of Hashimotos Autoimmune Thyroiditis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PLACEBO  once weekly for 8 weeks orally, followed by once a month for 16 weeks orally. 
Intervention  Vitamin D  60000 Units 25 Hydroxy-cholecalciferol: once weekly for 8 weeks orally, followed by once a month for 16 weeks orally. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Age more than 18 yrs

Gender both male and female

Positive anti TPO antibody more than 34 International Units per litre as per our hospital laboratory normal upper limit AND OR

Positive anti TG more than 20 International Units per litre as per our laboratory normal upper limit for anti TPO negative cases

Normal serum free T4 more than 1.9 nanogram per decilitre as per our laboratory normal upper limit
 
 
ExclusionCriteria 
Details  Diseases and drugs interfering with vitamin D metabolism like CKD Liver diseases chronic granulomatous diseases like TB sarcoidosis

Drugs including phenytoin phenobarbitone valproic acid cholestyramin rifampin orlistat corticosteroid or others

Any chronic medications that might interfere with thyroid hormone metabolism

Pregnant and lactating women

Those who received Vitamin D and calcium in the last 6 months
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Criteria based on thyroid function

Responders will be arbitrarily defined as at least 25 percent or greater reduction in serum TSH levels in mili International Units per litre from baseline value in the Intervention group AND OR

25 percent or greater reduction in serum anti TPO antibody titers in International Units per litre from baseline in the Intervention group 		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Criteria of sonographic response is arbitrarily defined as reduction in gland size by 25 percent from baseline OR

Any change in echogenicity of the whole gland or reduction in number or size of nodules by 25 percent from baseline

Criteria based on anthropometric variables

Responders will be arbitrarily defined as 25 percent or greater reduction in BMI in kg per square metres from baseline 		 1year 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/06/2017 
Date of Study Completion (India) 08/01/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 08/01/2019 
Estimated Duration of Trial   Years="1"
Months="11"
Days="29" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a randomized placebo controlled double blinded trial to ascertain the beneficial effects of vitamin D in patients of subclinical hypothyroid disease due to autoimmune thyroiditis as validated by anti thyroid peroxidase and or anti thyroglobulin positivity. although vitamin D has been established as having a proven immunomodulatory function in several clinical and pre clinical studies, its role in ameliorating the pathophysiology of autoimmunity  in Hashimoto’s thyroiditis has not been amply studied in clinical trials. There are few pre clinical trials to prove that vitamin D can actually suppress the autoimmune response of B and T cells and inflammatory markers, thereby arresting autoimmune thyroid destruction in vitro. Few studies outside India, in Serbia, Iran have found a positive correlation between regression of autoimmune thyroiditis and Vitamin D therapy  in human clinical trials. However such randomized placebo controlled human studies in Indian subcontinent is lacking distinctly, despite the known fact that both vitamin D deficiency and autoimmune Hashimoto’s thyroiditis are both rampantly existent diseases in Indian population. This study aims to explore this as yet unproven prospect especially in the Indian context by supplementing 60000 units of vitamin D to subclinical subjects of autoimmune hypothyroidism for a period of 6 months and the outcome is expected to demonstrate a clear benefit of this wonder vitamin in thyroid autoimmune disorders. A total of 140 subjects will be enrolled in the study and, after measuring  baseline variables,  given either placebo or 60000 units of vitamin D sachet every week for 2 months followed by every month for total 6 months followed by repeitition of same variables at follow up to ascertain any change. All data will be recorded and standard statistical methods applied to obtain results and final conclusion will be inferred. 
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