This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Recurrent aphthous stomatitis (RAS), also known as canker sores, is the most common soft tissue disease of the mouth in humans in all geographic regions, including Connecticut. In a large study of over 10,000 young adults, 38.7% of men and 49.7% of women reported two or more previous occurrences of RAS. These ulcerations are painful and affect the patient's ability to eat and drink. Further, they may also impact on oral hygiene practices and speech. Thus, RAS has a significant effect on the patient's quality of life. There is currently no known method to prevent RAS. Topical and/or systemic steroids are sometimes used for the treatment of this condition. However, because these drugs have significant side-effects, they are used only for the treatment of the most severe cases. The vast majority of patients with RAS do not have any scientifically validated options for prevention or treatment. Several studies have demonstrated that patients with RAS are more likely to have lower blood levels of vitamins, such as B12 and folic acid, compared to healthy controls. More importantly, multiple studies have demonstrated that specific replacement therapy to correct such deficiencies is effective in inducing improvement or remission of this disease. A workshop convened by the National Institutes of Health (NIH) recommended complete hematologic screening of all patients with RAS. However, testing for vitamin deficiencies is invasive and expensive. It is not feasible to take blood samples on every patient with RAS and test for such deficiencies. Therefore, this is rarely done in practice and patients continue to suffer from these lesions. This study proposes an alternative approach: To prevent RAS using a multivitamin supplement that would correct any deficiencies of factors known to commonly contribute to RAS. If successful, this would result in a simple, cost-effective approach to reducing the morbidity of this prevalent disease. We propose a double-blind, placebo-controlled clinical study in 120 subjects who suffer from RAS. Subjects will be randomly assigned to either a multivitamin supplement or an inactive placebo, in a 1:1 ratio (60 in each group). The study medication will be taken once a day for one year. We will document, in all subjects, the number of RAS episodes in one year and the duration of episodes. These will be compared between the two groups to find out if the multivitamin supplement was effective in reducing the number or duration of RAS episodes. We will also collect data on pain and normalcy of diet during RAS episodes to determine if the multivitamin supplement had any effect on these variables. To enhance subject compliance and retention, we will use Interactive Voice Recording (IVR) technology that uses the telephone to administer survey questions. A blood sample will be collected from all consenting subjects at baseline. This blood sample will be used to measure the baseline levels of vitamins B12 and B9 (folic acid). These are the principal vitamins whose deficiency has been associated with RAS. All subjects will be asked to complete a Diet History Questionnaire at the beginning and at the end of the study. The purpose of this questionnaire is to estimate dietary intake of the vitamins being supplemented, at baseline and over the one-year period of the study. pard
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