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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT00779909
First received: October 22, 2008
Last updated: August 2, 2012
Last verified: August 2012
  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
Drug: vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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 ]

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
placebo
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779909

Locations
United States, Massachusetts
Boston University Goldman School of Dental Medicine
Boston, Massachusetts, United States, 02118
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
ClinicalTrials.gov Identifier: NCT00779909     History of Changes
Other Study ID Numbers: BU-AT003714, R21AT003714-01
Study First Received: October 22, 2008
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 23, 2014