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| ID | Type | Description | Link |
|---|---|---|---|
| DF 04-005 | Other Grant/Funding Number | Donaghue Medical Research Foundation |
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| Name | Class |
|---|---|
| Donaghue Medical Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| II - Inactive Medication | Placebo Comparator | The placebo will be a gelatin capsule filled with lactose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multivitamin | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Annual number and average duration of minor recurrent aphthous stomatitis (canker sores) episodes | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Pain due to recurrent aphthous stomatitis (canker sores); impact of recurrent aphthous stomatitis on ability to consume a normal diet | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh V. Lalla, DDS,PhD,CCRP | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22467697 | Result | Lalla RV, Choquette LE, Feinn RS, Zawistowski H, Latortue MC, Kelly ET, Baccaglini L. Multivitamin therapy for recurrent aphthous stomatitis: a randomized, double-masked, placebo-controlled trial. J Am Dent Assoc. 2012 Apr;143(4):370-6. doi: 10.14219/jada.archive.2012.0179. | |
| 22077475 | Result | Huling LB, Baccaglini L, Choquette L, Feinn RS, Lalla RV. Effect of stressful life events on the onset and duration of recurrent aphthous stomatitis. J Oral Pathol Med. 2012 Feb;41(2):149-52. doi: 10.1111/j.1600-0714.2011.01102.x. Epub 2011 Nov 12. |
| Label | URL |
|---|---|
| Publication describing results of this study | View source |
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| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| D001361 | Avitaminosis |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003677 | Deficiency Diseases |
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| ID | Term |
|---|---|
| C067316 | Geritol |
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| 20141576 | Result | Kozlak ST, Walsh SJ, Lalla RV. Reduced dietary intake of vitamin B12 and folate in patients with recurrent aphthous stomatitis. J Oral Pathol Med. 2010 May;39(5):420-3. doi: 10.1111/j.1600-0714.2009.00867.x. Epub 2010 Feb 7. |
| Publication describing results of this study | View source |
| Publication describing results of this study | View source |
| D044342 |
| Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |