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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Clinical parameters assessed are
研究概览
简要总结
| 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Clinical parameters assessed are
时间窗: Baseline, 8th week, 12 months
Number of ulcers of Recurrent Aphthous Stomatitis
时间窗: Baseline, 8th week, 12 months
Size of ulcers of RAS
时间窗: Baseline, 8th week, 12 months
Frequency of RAS
时间窗: Baseline, 8th week, 12 months
Healing Time of RAS
时间窗: Baseline, 8th week, 12 months
VAS score
时间窗: Baseline, 8th week, 12 months
次要结局
- Serum Vitamin D levels at(Baseline and at the end of eight weeks and 12 months of oral Vitamin D3 supplementation)
- Serum TNF-alpha levels at(Baseline and at the end of eight weeks of oral Vitamin D3 supplementation)
研究者
Dr Revanth Rao E
Government Dental College and Research Institute Bangalore
