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临床试验/CTRI/2024/04/065605
CTRI/2024/04/065605尚未招募3 期

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

Government Dental College and Research Institute Bangalore1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年4月16日最近更新:

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

发起方
Government Dental College and Research Institute Bangalore
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Revanth Rao E

Government Dental College and Research Institute Bangalore

研究点 (1)

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