Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
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 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.
Phase:
Early Phase 1
Details
Lead Sponsor:
Boston University
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Treatments:
Anti-Inflammatory Agents Cholecalciferol Ergocalciferols Vitamin D Vitamins