Prevention of Recurrent Aphthous Stomatitis Using Vitamins - Full Text View

Sponsor:	University of Connecticut Health Center
Collaborator:	Donaghue Medical Research Foundation
Information provided by:	University of Connecticut Health Center
ClinicalTrials.gov Identifier:	NCT00527306

Purpose

The purpose of this research study is to find out if taking a multivitamin daily can affect the number of canker sores that people get and how long they last. Previous studies have shown that people who get canker sores are more likely to be deficient in one or more vitamins. It has also been found that correction of such vitamin deficiencies reduces the number and duration of canker sores. However, it is not known if taking a multivitamin daily will reduce the number and duration of canker sores.

Condition	Intervention	Phase
Aphthous Stomatitis	Dietary Supplement: multivitamin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Prevention of Recurrent Aphthous Stomatitis Using Vitamins

Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:

Annual number and average duration of minor recurrent aphthous stomatitis (canker sores) episodes [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain due to recurrent aphthous stomatitis (canker sores); impact of recurrent aphthous stomatitis on ability to consume a normal diet [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	160
Study Start Date:	December 2005
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: I - Multivitamin The multivitamin will contain 100% of the US reference daily intakes (recommended daily amounts) of vitamins A, B1, B2, B3, B5, B6, B9, B12, C, D, and E. It also contains several inactive ingredients including sodium bisulfite and gelatin.	Dietary Supplement: multivitamin Subject will be asked to take a multivitamin capsule or a placebo (inactive pill) once a day for one year. There will be an equal chance of getting the multivitamin or the placebo.
Placebo Comparator: II - Inactive Medication The placebo will be a gelatin capsule filled with lactose.	Dietary Supplement: multivitamin Subject will be asked to take a multivitamin capsule or a placebo (inactive pill) once a day for one year. There will be an equal chance of getting the multivitamin or the placebo.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients willing and able to provide written informed consent for the study
Patients with a history of at least three episodes of minor recurrent aphthous stomatitis (RAS) within the past one year

Exclusion Criteria:

Patients with a history of other forms of RAS (major, herpetiform)
Patients who will be using any other vitamins/supplements during the study or those who have used any vitamins/supplements on a regular basis during the 90 days immediately preceding enrollment onto the study (regular use is defined as continuous daily use for at least a two week period)
Patients who are under the age of 18
Women who are pregnant or nursing or those who plan to become pregnant
Patients with a history of gout, kidney stones or iron overload disease
Patients who currently smoke tobacco products
Patients who are former smokers who have quit smoking within the past 30 days
Patients with sulfite allergy
Patients with a history of any systemic condition associated with oral ulceration. These include: Behcet's syndrome, Sweet's syndrome, Celiac disease, Crohn's disease, ulcerative colitis, HIV infection/AIDS, cyclic neutropenia and PFAPA syndrome (periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis)
Patients on medications commonly associated with causing oral ulceration. These include nicorandil, methotrexate and chemotherapeutic agents used for cancer.
Patients using oral topical anti-inflammatory agents during the course of the study
Patients who plan to use any products specifically for management of RAS lesions
Patients who are routinely using agents that could have an impact on duration of RAS lesions (e.g., antibacterial mouthrinses)
Patients receiving any other investigational agent during the course of ths study
Patients with any other condition that might preclude participation in the study in the opinion of the study investigators

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527306

Locations

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06032

Sponsors and Collaborators

University of Connecticut Health Center

Donaghue Medical Research Foundation

Investigators

Principal Investigator:

Rajesh V. Lalla, DDS,PhD,CCRP

University of Connecticut Health Center

More Information

No publications provided

Responsible Party:	Dr. Rajesh V. Lalla, University of Connecticut Health Center
ClinicalTrials.gov Identifier:	NCT00527306 History of Changes
Other Study ID Numbers:	06-022-1, DF 04-005
Study First Received:	September 6, 2007
Last Updated:	March 30, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:

aphthous stomatitis
canker sores
multivitamins
vitamin deficiency

Additional relevant MeSH terms:

Stomatitis
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases
Vitamins

Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012