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OpenTrials
Completed

NCT Number: NCT00527306

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multivitamin

Dietary Supplement

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.

Primary outcomes

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

    Time frame: one year

Secondary outcomes

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

    Time frame: one year

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Donaghue Medical Research Foundation

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 10, 2007
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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