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

Recurrent Aphthous Stomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01127724
• Other study ID #: MMC105709KCTIL
• Status: Terminated
• Phase: N/A
• First received: May 20, 2010
• Last updated: November 18, 2014
• Start date: June 2012
• Est. completion date: October 2014

Study information

• Verified date: April 2013
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Recurrent Aphthous Stomatitis
• Stomatitis
• Stomatitis, Aphthous

Intervention

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

Locations

Country	Name	City	State
Israel	Clalit Health Service (HMO)	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of recurrent aphthous stomatitis (RAS)		12 months	No
Secondary	severity of recurrent aphthous stomatitis (RAS)		12 months	No