An interventional study of vitamin B12 treatment in Recurrent Aphthous Stomatitis, sponsored by Meir Medical Center. Terminated at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-19.
Sponsored by Meir Medical Center · Not applicable, Interventional, and Treatment
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
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 8 is below the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →Meir Medical Center is the lead sponsor of 401 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Group I- will receive sublingual vitamin B12 treatment, 1000 mcg per day for 6 months
Drug: vitamin B12 treatment
Group II- will receive sublingual vitamin B12 treatment, 100 mcg per day for 6 months
Drug: vitamin B12 treatment
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
Also known as: vitamin B12
frequency of recurrent aphthous stomatitis (RAS)
Time frame: 12 months
severity of recurrent aphthous stomatitis (RAS)
Time frame: 12 months
The record gives a start of Jun 2012, a primary completion of Oct 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin B 12