Recurrent Aphthous StomatitisNCT01127724
Influence of Different Doses of the Vitamin B12 on Recurrent Aphthous Stomatitis
A study testing vitamin B12 treatment in people with Recurrent Aphthous Stomatitis, run by Meir Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Aphthous Stomatitis
- What is being tested?
- vitamin B12 treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and older
- Suffer from RAS For at least one year, with aphthous frequency at least once a month.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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
- Conditions
- Recurrent Aphthous Stomatitis
- Being tested
- vitamin B12 treatment
- Keywords
- Vitamin B12, Aphthous stomatitis, Cobalamin, Doses
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin B12 treatmentDrug
Also called vitamin B12
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
| Study group | Role | What they receive |
|---|---|---|
| group 1- 1000 mcg | Experimental | Group I- will receive sublingual vitamin B12 treatment, 1000 mcg per day for 6 months Receives: Drug: vitamin B12 treatment |
| Group 2- 100 mcg | Experimental | Group II- will receive sublingual vitamin B12 treatment, 100 mcg per day for 6 months Receives: Drug: vitamin B12 treatment |
| group 3- 2000 mcg | Experimental | Group III- will receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months Receives: Drug: vitamin B12 treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of recurrent aphthous stomatitis (RAS)
Measured: 12 months
Secondary outcomes (1)
severity of recurrent aphthous stomatitis (RAS)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startJun 2012
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: difficulties in recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Aphthous StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Press, MD, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127724
- Sponsor's protocol ID
- MMC105709KCTIL
- Status last verified
- Apr 2013
- First submitted
- 20 May 2010
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Doses of the Vitamin B12 on Recurrent Aphthous Stomatitis
- ClinicalTrials.gov ID
- NCT01127724
- Acronym / sponsor ID
- MMC105709KCTIL
- Conditions
- Recurrent Aphthous Stomatitis
- Keywords
- Vitamin B12, Aphthous stomatitis, Cobalamin, Doses
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties in recruiting participants
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1- 1000 mcg | Experimental | Drug: vitamin B12 treatmentGroup I- will receive sublingual vitamin B12 treatment, 1000 mcg per day for 6 months |
| Group 2- 100 mcg | Experimental | Drug: vitamin B12 treatmentGroup II- will receive sublingual vitamin B12 treatment, 100 mcg per day for 6 months |
| group 3- 2000 mcg | Experimental | Drug: vitamin B12 treatmentGroup III- will receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 and older
- Suffer from RAS For at least one year, with aphthous frequency at least once a month.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin B12 treatmentAlso: vitamin B12Group 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 | Drug | Group 2- 100 mcg, group 1- 1000 mcg, group 3- 2000 mcg |
Primary outcome
frequency of recurrent aphthous stomatitis (RAS)
Time frame: 12 months
1 secondary outcome
severity of recurrent aphthous stomatitis (RAS)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: difficulties in recruiting participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Press, MD principal investigator
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin B12 treatment in people with Recurrent Aphthous Stomatitis, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulties in recruiting participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of recurrent aphthous stomatitis (RAS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.