Prevention of Recurrent Aphthous Stomatitis Using Vitamins

NCT00527306 | Completed Phase 3

• 2 other identifiers: 06-022-1DF 04-005
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphthous Stomatitis

Keywords

aphthous stomatitis; canker sores; multivitamins; vitamin deficiency

Outcome Measures

Primary Outcomes (1)

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

  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

  one year

Study Arms (2)

I - Multivitamin

EXPERIMENTAL

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

II - Inactive Medication

PLACEBO COMPARATOR

The placebo will be a gelatin capsule filled with lactose.

Dietary Supplement: multivitamin

Interventions

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.

I - Multivitamin; II - Inactive Medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• Donaghue Medical Research Foundation: collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06032, United States

Location

Related Publications (3)

• 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.

  PMID: 22467697 RESULT

• 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.

  PMID: 22077475 RESULT

• 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.

  PMID: 20141576 RESULT

Related Links

• Publication describing results of this study
• Publication describing results of this study
• Publication describing results of this study

MeSH Terms

Conditions

Stomatitis, Aphthous; Avitaminosis

Interventions

Geritol

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Rajesh V. Lalla, DDS,PhD,CCRP

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: December 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

US (1)