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CTRI Number  CTRI/2024/03/064610 [Registered on: 21/03/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of Vitamin D level COVID-vaccinated patients 
Scientific Title of Study   VDR mRNA expression and serum Vit. D levels in Post Covid vaccinated patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandesh Dipchand Shende 
Designation  Junior Research Fellow 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Clinical Research Central Research Laboratory Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MH 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9518322608  
Fax    
Email  sandeshshende96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jaishriram Rathored 
Designation  Associate Professor and In charge CRL and Molecular Diagnostics 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Clinical Research Central Research Laboratory Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MH 442001

Wardha
MAHARASHTRA
442001
India 
Phone  8319380593  
Fax    
Email  jaishriz@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jaishriram Rathored 
Designation  Associate Professor and In charge CRL and Molecular Diagnostics 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Clinical Research Central Research Laboratory Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha MH 442001

Wardha
MAHARASHTRA
442001
India 
Phone  8319380593  
Fax    
Email  jaishriz@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Wardha 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College  
Address  DMIHER Campus Sawangi Meghe Wardha MH 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandesh Dipchand Shende  Datta Meghe Institute of Higher Education and Research  Department of Clinical Research Central Research Laboratory Ground Floor Auditorium Building Sawangi Meghe Wardha
Wardha
MAHARASHTRA 
9518322608

sandeshshende96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants of either gender aged between 18-65 years
2. Covid-19 Vaccination done (Covishield, Covaxin, Sputnik-V and other related brands)
3. Free from Co-morbid diseases (TB, HIV, Diabetes, Hypertension, etc)
4. Participants ready to provide written, informed consent.
 
 
ExclusionCriteria 
Details  1. Pregnant and lactating Mother
2. Comorbid conditions (TB, HIV, Diabetes, Hypertension)
3. Those who have not received any vaccination for COVID-19
4. Those who have received any vaccination other than COVID-19 in the last 5 years at the time of recruitment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To study the mRNA expression levels of VDR genes in PBMCs of post-vaccinated patients.
2. To identify the potential associations between VDR mRNA expression levels and other biochemical parameters in post-vaccinated patients.
 
Assessment will be done at the end of 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
3. To study the correlation of VDR mRNA expression with vit D, calcium (ionized & total), and iPTH levels
4. To study the possible correlation of vitamin D deficiency in post covid infection and normal controls (Normal control is defined as “healthy Subjects without Covid infection”)
 
3rd year 
 
Target Sample Size   Total Sample Size="204"
Sample Size from India="204" 
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)   14/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="11"
Days="28" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
Protocol Published in F1000 Research Journal 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  This is PhD thesis data and we are not giving any intervention. So IPR is Excluded from the study trial.

  2. What additional supporting information will be shared?
    Response (Others) -  In the form of Publication
  3. Who will be able to view these files?
    Response (Others) -  In the form of Publication

  4. For what types of analyses will this data be available?
    Response (Others) -  In the form of Publication

  5. By what mechanism will data be made available?
    Response (Others) -  In the form of Publication

  6. For how long will this data be available start date provided 08-06-2026 and end date provided 08-10-2034?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

In the global pursuit of ending the COVID-19 pandemic, vaccination campaigns are known as a ray of hope, bringing in a new era of healing and adaptation. While vaccines have played a main role in mitigating the devastating impact of the virus, they have also prompted numerous questions about their effects on the human body, especially in molecular biology. Among the myriad questions that have arisen, one has particularly intrigued scientists and clinicians alike: How do COVID-19 vaccines impact the expression of the Vitamin D Receptor (VDR) mRNA in the human body, and what could this mean for our understanding of immune responses and overall health? 

The COVID-19 outbreak has challenged healthcare professionals throughout the world with challenges that have never been encountered before. Numerous lives have been saved as a result of the vital role that quick vaccine development and distribution have played in controlling the virus’s spread1. But there is still much to learn about the complex interactions between vaccinations, the immune system’s function, and other biological functions. 

The VDR, a vital part of the immune system in humans, is well-known for its crucial function in controlling immunological responses, regulating inflammation pathways, and maintaining general health2. Vitamin D, commonly referred to as the " vitamin of sunshine," is essential for controlling the expression of VDR3. Variations in VDR mRNA levels of expression may affect how each person reacts to vaccines and viral illnesses, according to recent research4

Gaining a thorough grasp of how COVID-19 immunization affects VDR mRNA expression is crucial as the globe struggles with COVID-19 and its continuous mutations5. Additionally, it can provide insightful information on individualized vaccination plans and the creation of innovative treatments to improve vaccine responses. 

In this investigation, we set out to understand the complex molecular dynamics of VDR mRNA expression in post-COVID-vaccinated patients. I hope to give a comprehensive view of how COVID-19 vaccinations affect the expression of this important receptor by diving into the worlds of molecular biology, and immunology. To understand the molecular symphony that directs our immune response to COVID-19 immunization, our work makes use of cutting-edge methodologies, extensive data analysis, and multidisciplinary collaboration. 

We want to further my knowledge of the intricate relationships among vaccines, the immune system, and human genetics through this endeavour, bridging the gap between scientific curiosity and useful healthcare applications. As we journey through the labyrinthine pathways of VDR mRNA expression, my goal is not only to shed light on its modulation but also to illuminate new avenues for harnessing this knowledge to strengthen our defences against current and future pandemics.  

 
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