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CompletedNCT00527306Updated Aug 27, 2020

Prevention of Recurrent Aphthous Stomatitis Using Vitamins

A Phase 3 interventional study of multivitamin in Aphthous Stomatitis, sponsored by UConn Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-27.

Sponsored by UConn Health · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aphthous Stomatitis

Keywords

  • aphthous stomatitis
  • canker sores
  • multivitamins
  • vitamin deficiency
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
160 participants (actual)

Study arms

  • 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.

    Dietary Supplement: multivitamin

  • Placebo comparator
    II - Inactive Medication

    The placebo will be a gelatin capsule filled with lactose.

    Dietary Supplement: multivitamin

Interventions

  • Dietary supplementmultivitamin

    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.

05

What researchers measure

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

06

Study locations

1 site
  • University of Connecticut Health Center
    Farmington, Connecticut 06032, United States
07

References and documents

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. PubMed 22467697 ↗
  • 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. PubMed 22077475 ↗
  • 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. PubMed 20141576 ↗
08

Registry details

Key details

Study ID
NCT00527306
Lead sponsor
UConn Health
Collaborators
Donaghue Medical Research Foundation
Responsible party
Rajesh Lalla (Professor, UConn Health) — Principal investigator
First posted
Sep 10, 2007
Start date
Dec 2005
Primary completion
Jul 2009
Completion
Jul 2009
Last update
Aug 27, 2020

Study contacts

Rajesh V. Lalla, DDS,PhD,CCRP
principal investigator · UConn Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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