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Prevention of Recurrent Aphthous Stomatitis Using Vitamins

Primary Purpose

Aphthous Stomatitis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

multivitamin

About this trial

This is an interventional treatment trial for Aphthous Stomatitis focused on measuring aphthous stomatitis, canker sores, multivitamins, vitamin deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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Prevention of Recurrent Aphthous Stomatitis Using Vitamins

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