Oral Vitamin B12 as Potential Treatment of Recurrent Aphthous Stomatitis - Full Text View

Sponsored by:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00288769

Purpose

Background:

Recurrent aphthous stomatitis is a common phenomenon in Primary Medicine.Frequency of the phenomenon can be as high as 25% of the general population and the recurrence of the problem can be up to 50%.Different approaches for treatment are described: treatment with various natural vitamins , local ointments , disinfectant agents for local treatment , local antibiotic ointments , NSAID, local cortisone-steroids , and even medication on the basis of immune-depressants of the immune system and systematic steroids .

Methods:

A double-blind study of daily administration of sublingual Vitamin B12 tablets manufactured by Solgar (each tablet containing 1000 mcg. of Vitamin B12) opposed to placebo tablets.

Purpose of the research:

To investigate the effect of Vitamin B12 on the frequency of recurrent canker sores of the mouth (RAS).

Study hypothesis:

Treatment with vitamin B12 will reduce the recurrence rate and will diminish the symptomatology of RAS episodes.

Condition	Intervention
Recurrent Aphthous Stomatitis	Drug: daily sublingual tablets Vitamin B12 1000 mcg versus placebo

Drug Information available for: Vitamin B 12 Hydroxocobalamin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Soroka University Medical Center:

Study Start Date:	March 2006
Study Completion Date:	January 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2	Drug: daily sublingual tablets Vitamin B12 1000 mcg versus placebo

Show Detailed Description

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Over 18 years old.
Suffering from RAS as least for one year with a frequency of at least one sore per month

Exclusion Criteria:

Known systemic diseases concurrent with lesions in the mouth (Behcet's disease, jaundice, Rheumatism, Aides).
Does not speak Hebrew, Russian, or English.
Patients who have received in the last year Vit. B12 in any form.
Patients who receive other treatment for RAS.
Pregnant or nursing mothers.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288769

Locations

Israel
Ben-Gurion University of the Negev
Beer Sheva, Israel

Sponsors and Collaborators

Soroka University Medical Center

Investigators

Principal Investigator:

Ilia Volkov, MD

Ben-Gurion University of the Negev

More Information

Publications of Results:

Volkov Ilia, Inna Rudoy, Tamar Freud, Gabriel Sardal, Sody Naimer, Roni Peleg, Yan Press. Effectiveness of Vitamin B12 in Treating Recurrent Aphthous Stomatitis: A Randomized Double Blind Placebo Controlled Trial. J Am Board Fam Med 2009 22: 9-16.

Study ID Numbers:	SOR415705CTIL
Study First Received:	February 7, 2006
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00288769
Health Authority:	Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:

Recurrent aphthous stomatitis
vitamin B12

Study placed in the following topic categories:

Mouth Diseases
Stomatitis
Hydroxocobalamin
Vitamin B 12

Stomatognathic Diseases
Stomatitis, Aphthous
Aphthous stomatitis
Recurrence

Additional relevant MeSH terms:

Disease Attributes
Vitamin B Complex
Pathologic Processes
Hematinics
Therapeutic Uses
Growth Substances

Vitamins
Hematologic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009