Prevention of Recurrent Aphthous Stomatitis Using Vitamins

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Brief Title

Prevention of Recurrent Aphthous Stomatitis Using Vitamins

Official Title

Prevention of Recurrent Aphthous Stomatitis Using Vitamins

Brief Summary

      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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Annual number and average duration of minor recurrent aphthous stomatitis (canker sores) episodes

Secondary Outcome

 Pain due to recurrent aphthous stomatitis (canker sores); impact of recurrent aphthous stomatitis on ability to consume a normal diet

Condition

Aphthous Stomatitis

Intervention

multivitamin

Study Arms / Comparison Groups

 I - Multivitamin
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

160

Start Date

December 2005

Completion Date

July 2009

Primary Completion Date

July 2009

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rajesh V. Lalla, DDS,PhD,CCRP, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00527306

Organization ID

06-022-1

Secondary IDs

DF 04-005

Responsible Party

Principal Investigator

Study Sponsor

UConn Health

Collaborators

 Donaghue Medical Research Foundation

Study Sponsor

Rajesh V. Lalla, DDS,PhD,CCRP, Principal Investigator, UConn Health


Verification Date

August 2020