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临床试验/NCT00288769
NCT00288769已完成不适用

Oral Vitamin B12 as Potential Treatment of Recurrent Aphthous Stomatitis

Soroka University Medical Center1 个研究点 分布在 1 个国家开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
试验地点
1

研究概览

简要总结

Background:

Recurrent aphthous stomatitis is a common phenomenon in Primary Medicine.Frequency of the phenomenon can be as high as 25% of the general population and the recurrence of the problem can be up to 50%.Different approaches for treatment are described: treatment with various natural vitamins , local ointments , disinfectant agents for local treatment , local antibiotic ointments , NSAID, local cortisone-steroids , and even medication on the basis of immune-depressants of the immune system and systematic steroids .

Methods:

A double-blind study of daily administration of sublingual Vitamin B12 tablets manufactured by Solgar (each tablet containing 1000 mcg. of Vitamin B12) opposed to placebo tablets.

Purpose of the research:

To investigate the effect of Vitamin B12 on the frequency of recurrent canker sores of the mouth (RAS).

Study hypothesis:

Treatment with vitamin B12 will reduce the recurrence rate and will diminish the symptomatology of RAS episodes.

详细描述

Scientific Background:

Recurrent painful canker sores within the mouth (Recurrent aphthous stomatitis, RAS) are a common phenomenon in Primary Medicine (1,2). The term "aphthai" in Greek means a condition within the mouth and is attributed to Hippocrates. (1) RAS is characterized by small, recurrent, painful canker sores in the mouth. These sores have characteristic round or elliptical ulcerations with sharp edges. The sores have a red halo surrounding them and a base with a yellowish or grey color (1,3). Frequency of the phenomenon can be as high as 25% of the general population and the recurrence of the problem can be up to 50% (2).

RAS is idiopathic in most cases. A possible cause is frequently a local injury or stress. Other possible causes include systemic illness, nutritional deficiency, sensitivity or allergy to certain foods, illness that effect the immune system and medication. Even though RAS can be associated with celiac disease or Behcet's disease, most of the cases patients are presented with this problem there is no other complaint or symptom and the patient is considered healthy.

Since the cause of the condition is unknown, Diagnosis is based on the patient's history and on a physical examination. There is no laboratory test that can substantiate or negate the condition (4-7).

In medical literature different approaches for treatment are described: treatment with various natural vitamins (8), local ointments (9), disinfectant agents for local treatment (10), local antibiotic ointments (11), non-steroidal anti-inflammatory ointments (NSAID)(12), local cortisone-steroids (13), and even medication on the basis of immune-depressants of the immune system and systematic steroids (14-16).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years old.
  • Suffering from RAS as least for one year with a frequency of at least one sore per month

排除标准

  • Known systemic diseases concurrent with lesions in the mouth (Behcet's disease, jaundice, Rheumatism, Aides).
  • Does not speak Hebrew, Russian, or English.
  • Patients who have received in the last year Vit. B12 in any form.
  • Patients who receive other treatment for RAS.
  • Pregnant or nursing mothers.

研究组 & 干预措施

2

Other

干预措施: daily sublingual tablets Vitamin B12 1000 mcg versus placebo (Drug)

研究者

申办方类型
Other

研究点 (1)

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