| CTRI Number |
CTRI/2025/11/097901 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Impact of a Vitamin D Receptor Gene Change on Oral Precancer Risk |
|
Scientific Title of Study
|
FokI Vitamin D Receptor Gene Polymorphism and its correlation with precancerous lesions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Mithra N Hegde |
| Designation |
Principal |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics, AB Shetty Memorial Institute of Dental Science, Nitte (Deemed to be University), Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845284411 |
| Fax |
|
| Email |
drmithra.hegde@nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mithra N Hegde |
| Designation |
Principal |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics, AB Shetty Memorial Institute of Dental Science, Nitte (Deemed to be University), Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845284411 |
| Fax |
|
| Email |
drmithra.hegde@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Mithra N Hegde |
| Designation |
Principal |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics, AB Shetty Memorial Institute of Dental Science, Nitte (Deemed to be University), Dakshina Kannada, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845284411 |
| Fax |
|
| Email |
drmithra.hegde@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Vision Group on Science and Technology Karnataka Fund for Infrastructure Strengthening in Science and Technology- Level 2 (VGST KFIST-L2) |
|
|
Primary Sponsor
|
| Name |
VGST |
| Address |
7th Floor, 4th Gate, M.S. Building, Dr Ambedkar Rd, Ambedkar Veedhi, Bengaluru, Karnataka 560001 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nitte Deemed to be University |
Deralakatte, Mangalore- 575018 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Mithra N Hegde |
AB Shetty Memorial Institute of Dental Sciences, Nitte (Deemed to be University) |
Department of Conservative Dentistry and Endodontics, Deralakatte, Mangalore- 575018
Dakshina Kannada
KARNATAKA |
9845284411
drmithra.hegde@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central ethics committee Nitte University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals with oral precancerous lesions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants with and without precancerous lesions Healthy individuals who are under taking any nutriti onal supplements and are free from systemic diseases. |
|
| ExclusionCriteria |
| Details |
Subjects with a former positive history of other types of cancer or any type of systemic infections, endocrinological, metabolic, and inflammatory disease.
Patients with lipid-lowering drugs, oral antioxidants, or vitamin supplements.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse the oral health and its correlation with the rs2228570 single-nucleotide polymorphism in healthy individuals and individuals with precancerous lesions. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the distribution & frequency of the rs2228570 polymorphism between healthy individuals & those with precancerous lesions. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
01/01/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The FokI polymorphism in the Vitamin D Receptor (VDR) gene has been investigated for its potential role in susceptibility to various precancerous lesions, including oral leukoplakia, cervical dysplasia, colorectal adenomas, and others. This polymorphism results in structural changes in the VDR protein, influencing its ability to mediate the biological effects of vitamin D, such as cell proliferation, differentiation, and apoptosis. Several studies suggest that specific variants of the FokI polymorphism may alter cancer risk by affecting these cellular processes, thus establishing a genetic predisposition in the development of precancerous conditions. However, the correlation may vary across populations and lesion types, warranting further research for conclusive evidence. |