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

Sponsor

Meir Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT01127724

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Recurrent Aphthous Stomatitis	Drug: vitamin B12 treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group 1- 1000 mcg Group I- will receive sublingual vitamin B12 treatment, 1000 mcg per day for 6 months	Drug: vitamin B12 treatment 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 III- will receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months Other Names: vitamin B12
Experimental: Group 2- 100 mcg Group II- will receive sublingual vitamin B12 treatment, 100 mcg per day for 6 months	Drug: vitamin B12 treatment 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 III- will receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months Other Names: vitamin B12
Experimental: group 3- 2000 mcg Group III- will receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months	Drug: vitamin B12 treatment 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 III- will receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months Other Names: vitamin B12

Arm

Intervention/Treatment

Experimental: group 1- 1000 mcg

Group I- will receive sublingual vitamin B12 treatment, 1000 mcg per day for 6 months

Drug: vitamin B12 treatment

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 III- will receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months

Other Names:

vitamin B12

Experimental: Group 2- 100 mcg

Group II- will receive sublingual vitamin B12 treatment, 100 mcg per day for 6 months

Drug: vitamin B12 treatment

Other Names:

vitamin B12

Experimental: group 3- 2000 mcg

Group III- will receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months

Drug: vitamin B12 treatment

Other Names:

vitamin B12

Outcome Measures

Primary Outcome Measures

frequency of recurrent aphthous stomatitis (RAS) [12 months]

Secondary Outcome Measures

severity of recurrent aphthous stomatitis (RAS) [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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