Trial record 1 of 18 for:    "Aphthous stomatitis"
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Prevention of Recurrent Aphthous Stomatitis Using Vitamins

This study has been completed.
Sponsor:
Collaborator:
Donaghue Medical Research Foundation
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00527306
First received: September 6, 2007
Last updated: March 30, 2010
Last verified: March 2010
  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 3

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of Connecticut Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014