Prevention of Recurrent Aphthous Stomatitis Using Vitamins
Primary Purpose
Aphthous Stomatitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
multivitamin
Sponsored by
About this trial
This is an interventional treatment trial for Aphthous Stomatitis focused on measuring aphthous stomatitis, canker sores, multivitamins, vitamin deficiency
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
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
I - Multivitamin
II - Inactive Medication
Arm 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.
The placebo will be a gelatin capsule filled with lactose.
Outcomes
Primary Outcome Measures
Annual number and average duration of minor recurrent aphthous stomatitis (canker sores) episodes
Secondary Outcome Measures
Pain due to recurrent aphthous stomatitis (canker sores); impact of recurrent aphthous stomatitis on ability to consume a normal diet
Full Information
NCT ID
NCT00527306
First Posted
September 6, 2007
Last Updated
August 25, 2020
Sponsor
UConn Health
Collaborators
Donaghue Medical Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00527306
Brief Title
Prevention of Recurrent Aphthous Stomatitis Using Vitamins
Official Title
Prevention of Recurrent Aphthous Stomatitis Using Vitamins
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
Donaghue Medical Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphthous Stomatitis
Keywords
aphthous stomatitis, canker sores, multivitamins, vitamin deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I - Multivitamin
Arm Type
Experimental
Arm 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.
Arm Title
II - Inactive Medication
Arm Type
Placebo Comparator
Arm Description
The placebo will be a gelatin capsule filled with lactose.
Intervention Type
Dietary Supplement
Intervention Name(s)
multivitamin
Intervention Description
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 Outcome Measure Information:
Title
Annual number and average duration of minor recurrent aphthous stomatitis (canker sores) episodes
Time Frame
one year
Secondary Outcome Measure Information:
Title
Pain due to recurrent aphthous stomatitis (canker sores); impact of recurrent aphthous stomatitis on ability to consume a normal diet
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh V. Lalla, DDS,PhD,CCRP
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22467697
Citation
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.
Results Reference
result
PubMed Identifier
22077475
Citation
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.
Results Reference
result
PubMed Identifier
20141576
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3880249/
Description
Publication describing results of this study
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3323121/
Description
Publication describing results of this study
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3323114/
Description
Publication describing results of this study
Learn more about this trial
Prevention of Recurrent Aphthous Stomatitis Using Vitamins
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