| 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
|
|
|
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
|
|
|
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 infectionâ€)
|
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
- 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.
- What additional supporting information will be shared?
Response (Others) - In the form of Publication
- Who will be able to view these files?
Response (Others) - In the form of Publication
- For what types of analyses will this data be available?
Response (Others) - In the form of Publication
- By what mechanism will data be made available?
Response (Others) - In the form of Publication
- 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.
- 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. |