A Clinical Trial to study the effect of Vitamin D supplementation in patients with Minor Recurrent Aphthous Stomatitis having Vitamin D Deficiency

Phase 3

Conditions: Health Condition 1: K120- Recurrent oral aphthae

Registration Number: CTRI/2024/04/065605

Lead Sponsor: Government Dental College and Research Institute Bangalore

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical parameters assessed are <br/ ><br> <br/ ><br>Number of ulcers of Recurrent Aphthous Stomatitis <br/ ><br>Size of ulcers of RAS <br/ ><br>Frequency of RAS <br/ ><br>Healing Time of RAS <br/ ><br>VAS scoreTimepoint: Baseline, 8th week, 12 months

Secondary Outcome Measures

Name	Time	Method
Serum TNF-alpha levels at <br/ ><br>Baseline and at the end of eight weeks of oral Vitamin D3 supplementationTimepoint: Baseline and 8th week;Serum Vitamin D levels at <br/ ><br>Baseline and at the end of eight weeks and 12 months of oral Vitamin D3 supplementationTimepoint: Baseline, 8th week, 12 months