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Sponsored by: |
Boston University |
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Information provided by: | Boston University |
ClinicalTrials.gov Identifier: | NCT00779909 |
The burden of chronic gingivitis and periodontitis in the US is disproportionately high among Non-Hispanic Blacks compared to Non-Hispanic Whites. Chronic gingivitis is a highly prevalent chronic inflammatory disease that may progress into periodontitis, a major cause of tooth loss, Data from in-vitro and animal studies suggest anti-inflammatory effects of vitamin D; however, if and over what dose-range vitamin D may have anti-inflammatory effects in humans is uncertain. Recent clinical studies indicate that beneficial effects of vitamin D for several important outcomes may occur over a wide range of serum 25-hydroxyvitamin D (25-OHD) concentrations, possibly up to concentrations that would require vitamin D intakes ranging from 2 to more than 10 ten times higher than the current RDA for vitamin D. Because dark skin pigmentation is a potent inhibitor of vitamin D photosynthesis, Non-Hispanic Blacks have much lower 25-OHD serum levels than Non-Hispanic Whites. These differences in vitamin D status may partially explain the racial disparities in prevalence of chronic gingivitis and periodontitis observed in the US.
We hypothesize that oral cholecalciferol supplementation can reduce susceptibility to gingivitis over a wide range of serum 25-OHD concentrations in Non-Hispanic Whites and Non-Hispanic Blacks. We propose to conduct a simple, single-center, randomized, double-blind, placebo-controlled parallel-group dose-ranging study. We will compare placebo to doses of 500 IU, 2,500 IU and 5,000 IU vitamin D3 per day. We will compare the severity of gingival inflammation that develops in response to a 28-day period of unlimited plaque growth (experimental gingivitis) between dosage groups. Furthermore, we will evaluate the association between achieved 25-OHD levels and gingival inflammation. The results of this study will have several important implications, as dietary vitamin D supplementation may be a simple, safe and inexpensive means by which to reduce racial/ethnic disparities in gingivitis, as well as to reduce the overall burden of oral disease in the population as a whole. The study will elucidate the dose-response relationship of the anti-inflammatory effects of vitamin D, which in turn may lead to a revision of the current recommendations regarding nutritional supplementation of vitamin D in order to optimize the prevention of important medical conditions and diseases and reduce racial health disparities.
Condition | Intervention |
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Gingivitis |
Dietary Supplement: vitamin D3 |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Dose-Dependent Anti-Inflammatory Effects of Vitamin D in a Human Gingivitis Model |
Estimated Enrollment: | 120 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
placebo
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Dietary Supplement: vitamin D3
oral supplementation once per day for 12 weeks
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2: Experimental
500 IU
|
Dietary Supplement: vitamin D3
oral supplementation once per day for 12 weeks
|
3: Experimental
2500 IU
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Dietary Supplement: vitamin D3
oral supplementation once per day for 12 weeks
|
4: Experimental
5000 IU
|
Dietary Supplement: vitamin D3
oral supplementation once per day for 12 weeks
|
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Raul I Garcia, DMD | 617-6386385 | rig@bu.edu |
United States, Massachusetts | |
Boston University Goldman School of Dental Medicine | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Contact: Raul I Garcia, DMD 617-638-6385 rig@bu.edu | |
Principal Investigator: Raul I Garcia, DMD |
Principal Investigator: | Raul I Garcia, DMD | Boston University School of Dental Medicine |
Responsible Party: | Boston University Goldman School of Dental Medicine ( Raul I Garcia ) |
Study ID Numbers: | BU-AT003714, R21AT003714-01 |
Study First Received: | October 22, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00779909 History of Changes |
Health Authority: | United States: Food and Drug Administration |
vitamin D gingivitis periodontal disease inflammation |
Mouth Diseases Cholecalciferol Gingival Diseases Ergocalciferol Ergocalciferols Trace Elements Bone Density Conservation Agents Inflammation Periodontal Diseases |
Gingivitis Vitamin D Vitamin D2 Vitamin D3 Vitamins Calciferol Stomatognathic Diseases Micronutrients |
Mouth Diseases Cholecalciferol Gingival Diseases Growth Substances Physiological Effects of Drugs Ergocalciferols Bone Density Conservation Agents |
Pharmacologic Actions Periodontal Diseases Gingivitis Vitamin D Vitamins Stomatognathic Diseases Micronutrients |