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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  
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 
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  
Status 
Not Applicable 
 
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 
 
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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