Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00779909 · ClinicalTrials.gov registry record · Early Phase 1
Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model
A Early Phase 1 study, sponsored by Boston University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 35
- Enrollment target
NCT00779909 is a Early Phase 1 study that has completed, run by Boston University. The registered enrollment target is 35 participants.
The verdict
NCT00779909, a Early Phase 1 study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 35 participants
- Enrollment target
Study 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
Interventions
- OTHER Placebo
- DRUG vitamin D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-09 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00779909
The ClinicalTrials.gov registry entry for NCT00779909 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00779909 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00779909 about?
NCT00779909 is a clinical study titled "Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model". 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-vit...
What is the current status of trial NCT00779909?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 35 participants. The study started on 2008-12. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00779909?
The interventions under investigation include: Placebo (OTHER), vitamin D3 (DRUG).
Who is sponsoring clinical trial NCT00779909?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.