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Dose-Dependent Anti-Inflammatory Effects of Vitamin D in a Human Gingivitis Model
This study is currently recruiting participants.
Verified by Boston University, December 2008
First Received: October 22, 2008   Last Updated: December 10, 2008   History of Changes
Sponsored by: Boston University
Information provided by: Boston University
ClinicalTrials.gov Identifier: NCT00779909
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • proportion of sites that bleed on probing [ Time Frame: end of 4 week experimental gingivitis phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean modified gingival index [ Time Frame: end of 4 week experimental gingivitis phase ] [ Designated as safety issue: No ]
  • mean gingival crevicular fluid flow [ Time Frame: end of 4 week experimental gingivitis phase ] [ Designated as safety issue: No ]
  • GCF concentrations of IL1-beta, TNF-alpha, IL-2, IL-12 [ Time Frame: end of 4 week experimental gingivitis phase ] [ Designated as safety issue: No ]
  • serum calcium [ Time Frame: week 7, week 12 ] [ Designated as safety issue: Yes ]
  • urinary calcium / creatinine ratio [ Time Frame: week 4, week 7, week 12 ] [ Designated as safety issue: Yes ]
  • oral health related quality of life [ Time Frame: end of 4 week experimental gingivitis phase ] [ Designated as safety issue: No ]

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
1: Placebo Comparator
placebo
Dietary Supplement: vitamin D3
oral supplementation once per day for 12 weeks
2: Experimental
500 IU
Dietary Supplement: vitamin D3
oral supplementation once per day for 12 weeks
3: Experimental
2500 IU
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • informed written consent
  • healthy subjects age 18-64 years old
  • serum 25-hydroxyvitamin D concentration <62.5 nmol/L (<25 ng/mL)

Exclusion Criteria:

  • increased risk for infectious endocarditis that require antibiotic prophylaxis prior to periodontal probing
  • women who are postmenopausal
  • pregnancy or planned pregnancy within the period of the trial
  • Periodontitis (attachment loss ≥4 mm and probing depths≥5 mm on at least one interproximal site)
  • Any need for immediate dental treatment (can be eligible after completion of treatment)
  • history of hypercalcemia, malabsorption syndrome, abnormal sensitivity to vitamin D or hypervitaminosis D
  • < 3 teeth with bleeding on probing
  • < 20 teeth present or <8 interproximal spaces (i.e., papillae) in upper jaw
  • mean plaque index > 3
  • Current smoking or former smoking with cessation <5 years ago
  • regular use of any medication for prevention or treatment of disease (including Aspirin, NSAIDs, corticosteroids, but NOT including contraceptives)
  • Diabetes mellitus
  • hypercalcemia (serum calcium > ULN),
  • hypocalcemia (serum calcium < ULN),
  • hyperparathyroidism (serum PTH concentration > ULN),
  • hypoparathyroidism (serum PTH concentration < LLN)
  • any cardiac rhythm abnormalities on baseline ECG
  • use of tanning beds/unwillingness to abstain from use of tanning beds during study
  • planned travel during study period / unwillingness to abstain from travel to the South or High Altitudes
  • unwillingness to abstain from use of any supplements (including vitamin/mineral and herbal supplements) during study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779909

Contacts
Contact: Raul I Garcia, DMD 617-6386385 rig@bu.edu

Locations
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            
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Raul I Garcia, DMD Boston University School of Dental Medicine
  More Information

No publications provided

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

Keywords provided by Boston University:
vitamin D
gingivitis
periodontal disease
inflammation

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 01, 2009