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CTRI Number  CTRI/2025/07/090556 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 08/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Vitamin D supplementation 1000IU in the form of gummies]  
Study Design  Other 
Public Title of Study   Effects of Vitamin D gummies on caries causing bacteria in children 
Scientific Title of Study   Evaluation of Vitamin D supplementation on salivary parameters, streptococcus mutans and lactobacillus counts in children: A Prospective Randomized Open Blinded End Point(PROBE)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 Dipanshu kumar 
Designation  Assistant Professor 
Affiliation  Department of Dentistry, AIIMS, Gorakhpur 
Address  OPD Room no 8, Department of Dentistry, AIIMS, Gorakhpur

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9013190478  
Fax    
Email  drdipanshu.kumar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dipanshu kumar 
Designation  Assistant Professor 
Affiliation  Department of Dentistry, AIIMS, Gorakhpur 
Address  OPD Room no 8, Department of Dentistry, AIIMS, Gorakhpur

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9013190478  
Fax    
Email  drdipanshu.kumar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dipanshu kumar 
Designation  Assistant Professor 
Affiliation  Department of Dentistry, AIIMS, Gorakhpur 
Address  OPD Room no 8, Department of Dentistry, AIIMS, Gorakhpur

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9013190478  
Fax    
Email  drdipanshu.kumar@gmail.com  
 
Source of Monetary or Material Support  
Department of Dentistry, AIIMS, Gorakhpur, Uttar Pradesh 273008 
 
Primary Sponsor  
Name  Dr Dipanshu Kumar 
Address  OPD Room no 8, Department of Dentistry, AIIMS, Gorakhpur 273008, Uttar Pradesh, India 
Type of Sponsor  Other [Self] 
 
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 Dipanshu Kumar  AIIMS, Gorakhpur  OPD Room no 8, Department of Dentistry, Ground floor, AIIMS, Gorakhpur.
Gorakhpur
UTTAR PRADESH 
9013190478

drdipanshu.kumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC, AIIMS, Gorakhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children ages 6-12 years visiting Dentistry OPD 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Preventive dental care  Dental caries is one of the most prevalent chronic diseases affecting both adults and children globally. Vitamin D is being studied for its anti microbial property and its use in prevention and management of dental caries. This study aims to evaluate and compare the effects of Vitamin D 1000IU Gummies on salivary parameters like pH, buffering capacity, calcium, phosphate and counts of Streptococcus Mutans and Lactobacillus in children aged 6-12 years. 
Comparator Agent  Sugar free candies  Isomalt based sugarfree candies containing no added sugar used as control/placebo 
Comparator Agent  Vitamin D 1000IU  Vitamin D 1000IU in the form of sugar free gummies 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children aged 6 to 12 years with or without dental caries.
2.Participants must be in good general health as determined by a medical history and physical examination.
3.Parents or guardians must provide written informed consent, and children must provide assent.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The change in the counts of Streptococcus mutans and Lactobacillus in saliva.  1.Baseline
2.1 hour after one vitamin D (1000IU) gummy consumption
3.After 7 days of daily one vitamin D (1000IU) gummy consumption  
 
Secondary Outcome  
Outcome  TimePoints 
1. The change in the pH and buffering capacity of saliva.
2. The changes in salivary calcium and phosphorus levels  
1.Baseline
2.1 hour after one vitamin D (1000IU) gummy consumption
3.After 7 days of daily one vitamin D (1000IU) gummy consumption  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   01/08/2025 
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="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  

According to the Global Burden of Disease Study in 2017, oral diseases affect approximately 3.5 billion people worldwide, with dental caries being the most common condition. In children, especially those aged 6 to 12 years, dental caries can cause pain, difficulty eating, and disrupted sleep, adversely affecting their overall quality of life and development. Therefore, there is a critical need for effective preventive and management strategies for dental caries in this age group.

Vitamin D is a fat-soluble vitamin primarily known for its role in calcium and phosphate homeostasis and bone health. However, recent research has highlighted its pleiotropic effects, particularly its influence on the immune system. The active form of Vitamin D, 1,25-dihydroxyvitamin D, has been shown to modulate both innate and adaptive immune responses, including the production of antimicrobial peptides such as cathelicidin and defensins, which help maintain the microbial balance of mucosal surfaces. In the context of oral health, Vitamin D may contribute to a reduction in cariogenic bacteria through several mechanisms. Firstly, it promotes the expression of antimicrobial peptides in salivary glands and oral epithelium. Secondly, it enhances the oral mucosa’s physical barrier function and immune surveillance, thereby limiting bacterial colonization. Thirdly, studies have reported an inverse relationship between serum Vitamin D levels and dental caries prevalence in children and adults.

This study proposes to assess the impact of daily supplementation of 1000 IU of Vitamin D3 for 7 days on the salivary counts of S. mutans and Lactobacillus in healthy individuals. The results may provide valuable insights into the antimicrobial potential of Vitamin D in oral health maintenance.
 
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