Oral Vitamin B12 as Potential Treatment of Recurrent Aphthous Stomatitis
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2006
CompletedFirst Posted
Study publicly available on registry
February 8, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedJanuary 23, 2009
January 1, 2008
1.8 years
February 7, 2006
January 22, 2009
Conditions
Keywords
Study Arms (1)
2
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Over 18 years old.
- Suffering from RAS as least for one year with a frequency of at least one sore per month
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ben-Gurion University of the Negev
Beersheba, Israel
Related Publications (1)
Volkov I, Rudoy I, Freud T, Sardal G, Naimer S, Peleg R, Press Y. Effectiveness of vitamin B12 in treating recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled trial. J Am Board Fam Med. 2009 Jan-Feb;22(1):9-16. doi: 10.3122/jabfm.2009.01.080113.
PMID: 19124628RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilia Volkov, MD
Ben-Gurion University of the Negev
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 7, 2006
First Posted
February 8, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2007
Study Completion
January 1, 2008
Last Updated
January 23, 2009
Record last verified: 2008-01