Brief Title
Influence of Different Doses of the Vitamin B12 on Recurrent Aphthous Stomatitis
Official Title
Influence of Different Doses of the Vitamin B12 on Recurrent Aphthous Stomatitis
Brief Summary
Background: The frequency of recurrent aphthous stomatitis (RAS), the most common oral mucosa
lesions seen in primary care, is up to 25% in the general population. Sublingual vitamin B12
treatment, 1000 mcg per day for 6 months was found to be effective for patients suffering
from RAS, regardless of the serum vitamin B12 level. However, the optimal therapeutic dose of
vitamin B12 treatment remains unclear.
Working hypothesis and aims:
Aim-To assesses the influence of different vitamin B12 treatment doses on the frequency and
severity of RAS episodes.
Working hypothesis- The group receiving the higher dose of vitamin B12 treatment will have
the lower frequency and severity of RAS episodes; the reaction will be faster.
Methods: randomized, double blind, intervention study.
Study population: 75 patients in three groups (total of 225 patients):
Group I- will receive sublingual vitamin B12 treatment, 1000 mcg per day for 6 months Group
II- will receive sublingual vitamin B12 treatment, 100 mcg per day for 6 months Group I- will
receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months Study design: Study
participates will be followed through three study periods: The first period- three months
prior to receiving active treatment, the second period- six month of active treatment (with
randomization to study groups), and the third period- three month after finishing active
treatment. Frequency and severity of RAS episodes will be recorded by the patient with
"aphthous diary" that will be filled daily during all study period (12 months).
Expected results: This study will allow us to identify optimal dose of vitamin B12 treatment
that will achieve faster and longer remission of RAS episodes.
Importance: This is a very common problem in the population. Study results will help to
identify optimal doses of vitamin B12 needed to treat RAS.
Probable implications to Medicine: study results are supposed to give faster and better
treatment for RAS episodes
Study Type
Interventional
Primary Outcome
frequency of recurrent aphthous stomatitis (RAS)
Secondary Outcome
severity of recurrent aphthous stomatitis (RAS)
Condition
Recurrent Aphthous Stomatitis
Intervention
vitamin B12 treatment
Study Arms / Comparison Groups
group 1- 1000 mcg
Description: Group I- will receive sublingual vitamin B12 treatment, 1000 mcg per day for 6 months
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
8
Start Date
June 2012
Completion Date
October 2014
Primary Completion Date
October 2014
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 and older
- Suffer from RAS For at least one year, with aphthous frequency at least once a month.
Exclusion Criteria:
- known sensitivity to vitamin B12
- Don't speak Hebrew, Russian or English.
- Systemic Diseases, known in developing mouth aphthous (Behcet disease, Lupus
Erythematosus, rheumatoid arthritis and AIDS disease)
- Patients who have received last year any form of vitamin B12 .
- Patients who receive a different treatment to RAS(not for pain)
- Pregnant or breastfeeding women
- patient suffering from Leber's optic atrophy
- Patients who suffer from Psychosis
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Yan Press, MD, ,
Location Countries
Israel
Location Countries
Israel
Administrative Informations
NCT ID
NCT01127724
Organization ID
MMC105709KCTIL
Responsible Party
Sponsor
Study Sponsor
Meir Medical Center
Study Sponsor
Yan Press, MD, Principal Investigator, Ben-Gurion University of the Negev
Verification Date
April 2013