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Prevention of Recurrent Aphthous Stomatitis Using Vitamins
This study has been completed.
Study NCT00527306   Information provided by University of Connecticut Health Center
First Received: September 6, 2007   Last Updated: October 1, 2009   History of Changes

September 6, 2007
October 1, 2009
December 2005
July 2009   (final data collection date for primary outcome measure)
Annual number and average duration of minor recurrent aphthous stomatitis (canker sores) episodes [ Time Frame: one year ] [ Designated as safety issue: No ]
Annual number and average duration of minor recurrent aphthous stomatitis (canker sores) episodes [ Time Frame: one year ]
Complete list of historical versions of study NCT00527306 on ClinicalTrials.gov Archive Site
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 ]
Pain due to recurrent aphthous stomatitis (canker sores); impact of recurrent aphthous stomatitis on ability to consume a normal diet [ Time Frame: one year ]
 
Prevention of Recurrent Aphthous Stomatitis Using Vitamins
Prevention of Recurrent Aphthous Stomatitis Using Vitamins

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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Aphthous Stomatitis
Dietary Supplement: multivitamin
  • Experimental: 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.
  • Placebo Comparator: The placebo will be a gelatin capsule filled with lactose.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
160
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00527306
Dr. Rajesh V. Lalla, University of Connecticut Health Center
06-022-1, DF 04-005
University of Connecticut Health Center
Donaghue Medical Research Foundation
Principal Investigator: Rajesh V. Lalla, DDS,PhD,CCRP University of Connecticut Health Center
University of Connecticut Health Center
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP