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Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model

This study has been completed.
Information provided by (Responsible Party):
Boston University Identifier:
First received: October 22, 2008
Last updated: August 2, 2012
Last verified: August 2012

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
Drug: vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 ]

Secondary Outcome Measures:
  • mean modified gingival index [ Time Frame: end of 4 week experimental gingivitis phase ]
  • mean gingival crevicular fluid flow [ Time Frame: end of 4 week experimental gingivitis phase ]
  • GCF concentrations of IL1-beta, TNF-alpha, IL-2, IL-12 [ Time Frame: end of 4 week experimental gingivitis phase ]
  • serum calcium [ Time Frame: week 7, week 12 ]
  • urinary calcium / creatinine ratio [ Time Frame: week 4, week 7, week 12 ]
  • oral health related quality of life [ Time Frame: end of 4 week experimental gingivitis phase ]

Enrollment: 35
Study Start Date: December 2008
Study Completion Date: September 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Drug: vitamin D3
oral supplementation once per day for 12 weeks
Other Name: cholecalciferol
Experimental: 2
vitamin D3, 500 IU capsule once per day
Drug: vitamin D3
oral supplementation once per day for 12 weeks
Other Name: cholecalciferol
Experimental: 3
vitamin D3, 2500 IU capsule once per day
Drug: vitamin D3
oral supplementation once per day for 12 weeks
Other Name: cholecalciferol
Experimental: 4
vitamin D3, 5000 IU capsule once per day
Drug: vitamin D3
oral supplementation once per day for 12 weeks
Other Name: cholecalciferol


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00779909

United States, Massachusetts
Boston University Goldman School of Dental Medicine
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Principal Investigator: Raul I Garcia, DMD Boston University School of Dental Medicine
  More Information

Responsible Party: Boston University Identifier: NCT00779909     History of Changes
Other Study ID Numbers: BU-AT003714
R21AT003714-01 ( US NIH Grant/Contract Award Number )
Study First Received: October 22, 2008
Last Updated: August 2, 2012

Keywords provided by Boston University:
vitamin D
periodontal disease

Additional relevant MeSH terms:
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Vitamin D
Anti-Inflammatory Agents
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 27, 2017