Recruiting
Early Phase 1

Vitamin D

Sponsor:

Augusta University

Code:

NCT02337257

Conditions

Periodontal Disease

Vitamin D Deficiency

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Cholecalciferol

Placebo

Study Details

Brief summary:

Poor vitamin D status is very common in African Americans. Periodontitis (gum disease) are shown to be related to theincreased risk of cardiometabolic diseases. Vitamin D is freely available and cheap supplement that has shown beneficialeffect in the immune system regulation and maintenance of the cardiovascular health. In this study The investigators hypothesize thatvitamin D supplementation for 16 weeks in African Americans with periodontitis will result in clinical improvement in theirgum health as well as their cardiometabolic risk profile

Conditions

Periodontal Disease

Vitamin D Deficiency

Study ID

NCT02337257

Start date

Apr, 2014

Status verified date

Jan, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

1. You are African American
2. You have generalized chronic moderate to severe gum disease (periodontitis)
3. Your age is between 18-60 years.
4. You are not taking any vitamin, mineral or herbal supplements
5. If you are a female, you are not pregnant

Exclusion Criteria:

  • Not meeting any of the above

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: cholecalciferol

Subjects will take 4000 IU per day for 30 days

placebo comparator: Placebo

Subjects will take placebo everyday for 30 days

Interventions

Cholecalciferol

subjects will receive one pill per day which contains 4000 IU/d for 16 weeks

Placebo

subjects will receive placebo one pill per day for 16 weeks

Primary outcome measure

  • Change in Periodontal Disease Activity [ Time Frame: Baseline, 8 Weeks, 16 weeks. ]
  • Change in Cardiometabolic Risk Factors [ Time Frame: Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks. ]

Central Contacts and Locations

Central contacts

Yanbin Dong, PhD

706-721-5410ydong@gru.edu

Locations

Georgia Prevention Institute

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Anas Raed

706-721-1764

Principal Investigator:

Yanbin Dong, MD, PhD

More Information

Sponsor

Augusta University

Last update posted

Jan 13, 2015

Last verified

Jan, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2015-01-13.