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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014