| CTRI Number |
CTRI/2024/04/065605 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study the effect of Vitamin D supplementation in patients with Minor Recurrent Aphthous Stomatitis having Vitamin D Deficiency |
|
Scientific Title of Study
|
Effectiveness of oral vitamin D3 supplementation on clinical parameters and serum TNF alpha levels in subjects with minor recurrent aphthous stomatitis having hypovitaminosis D - A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Revanth Rao E |
| Designation |
Postgraduate |
| Affiliation |
Government Dental College and Research Institute Bangalore |
| Address |
Department of Oral Medicine and Radiology, Government Dental College and Research Institute, Victoria Hospital Campus, Fort, Bengaluru.
Bangalore KARNATAKA 560002 India |
| Phone |
8310794808 |
| Fax |
|
| Email |
revanthraje@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suman B |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Research Institute Bangalore |
| Address |
Department of Oral Medicine and Radiology, Government Dental College and Research Institute, Victoria Hospital Campus, Fort, Bengaluru.
Bangalore KARNATAKA 560002 India |
| Phone |
9980839659 |
| Fax |
|
| Email |
drsumanag99@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Revanth Rao E |
| Designation |
Postgraduate |
| Affiliation |
Government Dental College and Research Institute Bangalore |
| Address |
Department of Oral Medicine and Radiology, Government Dental College and Research Institute, Victoria Hospital Campus, Fort, Bengaluru.
Bangalore KARNATAKA 560002 India |
| Phone |
8310794808 |
| Fax |
|
| Email |
revanthraje@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral Medicine and Radiology, Government Dental College and Research Institute, Victoria Hospital Campus, Fort, Bengaluru. |
|
|
Primary Sponsor
|
| Name |
Government Dental College and Research Institute Bangalore |
| Address |
Department of Oral Medicine and Radiology, Government Dental College and Research Institute, Victoria Hospital Campus, Fort, Bengaluru. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Revanth Rao E |
Government Dental College and Research Institute Bangalore |
Department of Oral Medicine and Radiology, Government Dental College and Research Institute, Victoria Hospital Campus, Fort, Bengaluru. Bangalore KARNATAKA |
8310794808
revanthraje@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Dental College and Research Institute Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K120||Recurrent oral aphthae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsule Cholecalciferol 60,000 IU |
33 subjects will be prescribed 2% lignocaine anesthetic Gel along with weekly administration of Vitamin D3 (Cholecalciferol) 60,000 IU for 8 weeks and maintenance dose of vitamin D3 (Cholecalciferol) 60,000IU once per month for 10 months duration |
| Comparator Agent |
Placebo |
33 subjects will be prescribed 2% lignocaine anesthetic Gel for topical application to the ulcers (RAS) along with Oral Vitamin D3 matching placebos in a 2x2 factorial design given for same duration as experimental group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects aged 18 to 60 years of both genders, diagnosed according to Major and Minor Diagnostic criteria of Recurrent Aphthous Stomatitis as given by Natah et al in 2004. All four major and one minor criterion are to be fulfilled for diagnosis of RAS.
Subjects with Serum Vitamin D less than 30 ng/ml who voluntarily consented to be a part of the study |
|
| ExclusionCriteria |
| Details |
Subjects having received any systemic medication for Recurrent Aphthous Stomatitis(RAS) in the last three months.
Subjects with history of use of vitamin D supplements in a general multivitamin, along with calcium supplements or antioxidants or have already received Vitamin D3 as a treatment for another underlying disease at the time of the start of our study.
Subjects who were taking any drug affecting TNF-alpha levels or vitamin D metabolism in past six months.
Subjects with history of known allergy to vitamin D supplements
Subjects with any systemic disease affecting vitamin D metabolism.
Subjects with any oral ulcers other than RAS minor.
Habit of smoking
Pregnant and lactating females |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical parameters assessed are
Number of ulcers of Recurrent Aphthous Stomatitis
Size of ulcers of RAS
Frequency of RAS
Healing Time of RAS
VAS score |
Baseline, 8th week, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Serum Vitamin D levels at
Baseline and at the end of eight weeks and 12 months of oral Vitamin D3 supplementation |
Baseline, 8th week, 12 months |
Serum TNF-alpha levels at
Baseline and at the end of eight weeks of oral Vitamin D3 supplementation |
Baseline and 8th week |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/04/2024 |
| 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="1" Months="6" 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
|
|
Recurrent Aphthous Stomatitis (RAS) is a
widely prevalent inflammatory condition manifesting as recurrent, single or
multiple, shallow ,well-defined ,round or oval , painful ulcers in the oral
mucosa The three clinical forms of RAS are minor, major and herpetiform types,
among which minor RAS is the most
common variant. Multiple factors such as genetic
predisposition, immunological abnormalities, nutritional deficiencies,
infective agents, allergies, stress and local trauma have been implicated in
the etiology of RAS.
Abnormal expression of
pro-inflammatory cytokines including tumor necrosis
factor- alpha (TNF- α) in the oral
mucosa plays a crucial role in etiopathogenesis of RAS as it increases
cellular immune response in focal areas of the oral mucosa. TNF α production can be
inhibited by Vitamin D, a
multifunctional lipid-soluble hormone which has gained attention for its
immunomodulatory functions by regulation and modulation of innate and
acquired immune responses.
Numerous studies have identified
significantly reduced serum vitamin D levels in subjects with RAS and thus supplementation of oral vitamin D3
has been proposed as a safe promising intervention for the treatment of RAS
subjects with low serum vitamin D levels.
However, it is uncertain
whether supplementation with vitamin D3 would benefit all
persons with RAS. Since there are few studies pertaining to
supplementation of oral Vitamin D3 in RAS, the present study aims
to assess the effectiveness of oral Vitamin D3 supplementation on the
clinical parameters and serum TNF α levels in subjects with minor RAS.
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