Influence of Different Doses of the Vitamin B12 on Recurrent Aphthous Stomatitis

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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