- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00527306
Prevention of Recurrent Aphthous Stomatitis Using Vitamins
August 25, 2020 updated by: Rajesh Lalla, UConn Health
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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Farmington, Connecticut, United States, 06032
- University of Connecticut Health Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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Placebo Comparator: II - Inactive Medication
The placebo will be a gelatin capsule filled with lactose.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Annual number and average duration of minor recurrent aphthous stomatitis (canker sores) episodes
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain due to recurrent aphthous stomatitis (canker sores); impact of recurrent aphthous stomatitis on ability to consume a normal diet
Time Frame: one year
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rajesh V. Lalla, DDS,PhD,CCRP, UConn Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lalla RV, Choquette LE, Feinn RS, Zawistowski H, Latortue MC, Kelly ET, Baccaglini L. Multivitamin therapy for recurrent aphthous stomatitis: a randomized, double-masked, placebo-controlled trial. J Am Dent Assoc. 2012 Apr;143(4):370-6. doi: 10.14219/jada.archive.2012.0179.
- Huling LB, Baccaglini L, Choquette L, Feinn RS, Lalla RV. Effect of stressful life events on the onset and duration of recurrent aphthous stomatitis. J Oral Pathol Med. 2012 Feb;41(2):149-52. doi: 10.1111/j.1600-0714.2011.01102.x. Epub 2011 Nov 12.
- Kozlak ST, Walsh SJ, Lalla RV. Reduced dietary intake of vitamin B12 and folate in patients with recurrent aphthous stomatitis. J Oral Pathol Med. 2010 May;39(5):420-3. doi: 10.1111/j.1600-0714.2009.00867.x. Epub 2010 Feb 7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
September 6, 2007
First Submitted That Met QC Criteria
September 6, 2007
First Posted (Estimate)
September 10, 2007
Study Record Updates
Last Update Posted (Actual)
August 27, 2020
Last Update Submitted That Met QC Criteria
August 25, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-022-1
- DF 04-005 (Other Grant/Funding Number: Donaghue Medical Research Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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