Status:
COMPLETED
Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model
Lead Sponsor:
Boston University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Gingivitis
Eligibility:
All Genders
18-64 years
Phase:
EARLY_PHASE1
Brief Summary
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 infl...
Detailed Description
Vitamin D is important for healthy bones. More recently, anti-inflammatory effects of vitamin D have been found in laboratory and animal studies and vitamin D may be beneficial for inflammatory diseas...
Eligibility Criteria
Inclusion
- informed written consent
- healthy subjects age 18-64 years old
- serum 25-hydroxyvitamin D concentration \<62.5 nmol/L (\<25 ng/mL)
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00779909
Start Date
December 1 2008
End Date
September 1 2011
Last Update
October 2 2017
Active Locations (1)
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1
Boston University Goldman School of Dental Medicine
Boston, Massachusetts, United States, 02118