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Oral Vitamin B12 as Potential Treatment of Recurrent Aphthous Stomatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00288769
First Posted: February 8, 2006
Last Update Posted: January 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Soroka University Medical Center
  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
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00288769     History of Changes
Other Study ID Numbers: SOR415705CTIL
First Submitted: February 7, 2006
First Posted: February 8, 2006
Last Update Posted: January 23, 2009
Last Verified: January 2008

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

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