Trial record 3 of 17 for:    recurrent aphthous stomatitis

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01127724
First received: May 20, 2010
Last updated: June 27, 2013
Last verified: April 2013
  Purpose

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 Intervention
Recurrent Aphthous Stomatitis
Drug: vitamin B12 treatment

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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • frequency of recurrent aphthous stomatitis (RAS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • severity of recurrent aphthous stomatitis (RAS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: June 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127724

Contacts
Contact: Yan Press, M.D 972-8-6477433 yanp@bgu.ac.il

Locations
Israel
Clalit Health Service (HMO) Recruiting
Beer-Sheva, Israel
Contact: Yan Press, M.D    972-8-6477433    yanp@bgu.ac.il   
Principal Investigator: Yan Press, M.D         
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01127724     History of Changes
Other Study ID Numbers: MMC105709KCTIL
Study First Received: May 20, 2010
Last Updated: June 27, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
Vitamin B12
Aphthous stomatitis
Cobalamin
Doses

Additional relevant MeSH terms:
Stomatitis
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014