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Sponsors and Collaborators: |
University of Connecticut Health Center Donaghue Medical Research Foundation |
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Information provided by: | University of Connecticut |
ClinicalTrials.gov Identifier: | NCT00527306 |
The purpose of this research study is to find out if taking a multivitamin daily can affect the number of canker sores that people get and how long they last. Previous studies have shown that people who get canker sores are more likely to be deficient in one or more vitamins. It has also been found that correction of such vitamin deficiencies reduces the number and duration of canker sores. However, it is not known if taking a multivitamin daily will reduce the number and duration of canker sores.
Condition | Intervention | Phase |
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Aphthous Stomatitis |
Dietary Supplement: multivitamin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Prevention of Recurrent Aphthous Stomatitis Using Vitamins |
Enrollment: | 160 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I - Multivitamin: Experimental
The multivitamin will contain 100% of the US reference daily intakes (recommended daily amounts) of vitamins A, B1, B2, B3, B5, B6, B9, B12, C, D, and E. It also contains several inactive ingredients including sodium bisulfite and gelatin.
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Dietary Supplement: multivitamin
Subject will be asked to take a multivitamin capsule or a placebo (inactive pill) once a day for one year. There will be an equal chance of getting the multivitamin or the placebo.
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II - Inactive Medication: Placebo Comparator
The placebo will be a gelatin capsule filled with lactose.
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Dietary Supplement: multivitamin
Subject will be asked to take a multivitamin capsule or a placebo (inactive pill) once a day for one year. There will be an equal chance of getting the multivitamin or the placebo.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
University of Connecticut Health Center | |
Farmington, Connecticut, United States, 06032 |
Principal Investigator: | Rajesh V. Lalla, DDS,PhD,CCRP | University of Connecticut Health Center |
Responsible Party: | University of Connecticut Health Center ( Dr. Rajesh V. Lalla ) |
Study ID Numbers: | 06-022-1, DF 04-005 |
Study First Received: | September 6, 2007 |
Last Updated: | May 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00527306 History of Changes |
Health Authority: | United States: Institutional Review Board |
aphthous stomatitis canker sores multivitamins vitamin deficiency |
Mouth Diseases Aphthous Stomatitis Stomatitis Vitamins Trace Elements |
Micronutrients Stomatognathic Diseases Stomatitis, Aphthous Recurrence |
Mouth Diseases Stomatitis Growth Substances Vitamins Physiological Effects of Drugs |
Micronutrients Stomatognathic Diseases Stomatitis, Aphthous Pharmacologic Actions |