| 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
|
|
|
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
|
|
|
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 |
|
|
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. |