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

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 - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065605
Enrollment
66
Registered
2024-04-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K120- Recurrent oral aphthae

Interventions

Intervention1: 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

Sponsors

Government Dental College and Research Institute Bangalore
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Clinical parameters assessed are Number of ulcers of Recurrent Aphthous Stomatitis Size of ulcers of RAS Frequency of RAS Healing Time of RAS VAS scoreTimepoint: Baseline, 8th week, 12 months

Secondary

MeasureTime frame
Serum TNF-alpha levels at Baseline and at the end of eight weeks of oral Vitamin D3 supplementationTimepoint: Baseline and 8th week;Serum Vitamin D levels at Baseline and at the end of eight weeks and 12 months of oral Vitamin D3 supplementationTimepoint: Baseline, 8th week, 12 months

Countries

India

Contacts

Public ContactDr Revanth Rao E

Government Dental College and Research Institute Bangalore

drsumanag99@yahoo.com9980839659

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026