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Oral Vitamin B12 as Potential Treatment of Recurrent Aphthous Stomatitis

This study has been completed.
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00288769
First received: February 7, 2006
Last updated: January 22, 2009
Last verified: January 2008
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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:
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.

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

Keywords provided by Soroka University Medical Center:
Recurrent aphthous stomatitis
vitamin B12

Additional relevant MeSH terms:
Stomatitis
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013