Influence of Different Doses of the Vitamin B12 on Recurrent Aphthous Stomatitis
NCT ID: NCT01127724
Last Updated: 2014-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
8 participants
INTERVENTIONAL
2012-06-30
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
group 1- 1000 mcg
Group I- will receive sublingual vitamin B12 treatment, 1000 mcg per day for 6 months
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
Group 2- 100 mcg
Group II- will receive sublingual vitamin B12 treatment, 100 mcg per day for 6 months
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
group 3- 2000 mcg
Group III- will receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Suffer from RAS For at least one year, with aphthous frequency at least once a month.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Meir Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yan Press, MD
Role: PRINCIPAL_INVESTIGATOR
Ben-Gurion University of the Negev
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clalit Health Service (HMO)
Beersheba, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MMC105709KCTIL
Identifier Type: -
Identifier Source: org_study_id