Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans With Periodontal Disease (GumD)
Recruitment status was: Recruiting
Vitamin D Deficiency
Early Phase 1
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans|
- Change in Periodontal Disease Activity [ Time Frame: Baseline, 8 Weeks, 16 weeks. ]Periodontal disease activity will be measured using standard periodontal disease measures of pocket depth, blood on probing, periodontal inflamed surface area, plaque scores, bone loss, and clinical attachment loss
- Change in Cardiometabolic Risk Factors [ Time Frame: Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks. ]Cardiometabolic risk factors will be measured by pulse wave velocity, central and peripheral blood pressure and glycated hemoglobin (A1C)
- Change in Blood Myeloid Dendritic Cells [ Time Frame: Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks. ]Relative gene expression (transcripts) in blood myeloid dendritic cells (mDCs) by polymerase chain reaction (PCR) array, validated by protein, of markers of DC homeostasis and atherogenesis.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Active Comparator: cholecalciferol
Subjects will take 4000 IU per day for 30 days
subjects will receive one pill per day which contains 4000 IU/d for 16 weeks
Other Name: Vitamin D3
Placebo Comparator: Placebo
Subjects will take placebo everyday for 30 days
subjects will receive placebo one pill per day for 16 weeks
Other Name: sugar pill
This is a double-blind placebo-controlled randomized clinical trial of vitamin D supplementation.
The eligible subjects will be assigned to a specific group by random assignment in one of the following two groups:
- Group 1 who will receive placebo.
- Group 2 who will receive 4,000 IU vitamin D.
Both groups will receive either the placebo pills or vitamin D supplementation everyday for 16 weeks. At visit 1: a fasting morning urine sample will be collected. Height, weight, hip and waist circumferences will be measured. Automatic and manual blood pressures will be measured in sitting position. Approximately 80 ml of venous blood will be collected. Arterial stiffness will be assessed non-invasively by the SphygmoCor device. This device also measures the central (aortic) BP and simultaneously measures pulse wave velocity (PWV). A bottle of 30 capsules containing either vitamin D or placebo will be given to the subjects and will be asked to take one capsule every day for next month till the second visit. A questionnaire to assess the dietary habits, tobacco use, sun exposure, physical activity, socio-economic status and family health history will be given to the subject. At the dental clinic, full mouth clinical measurements (periodontal probing) will be performed. A plaque sample will be taken and a gum biopsy will be taken to examine the dendritic cells. Also, a saliva sample will be collected.
At visit 2: one month later, the supplements will be replenished, compliance will be assessed, and subjects will be examined for any potential side effects.
At visit 3: at 8-week follow up, anthropometric measures, blood samples as well as BP and PWV will be measured and the subject will be assessed for clinical improvement in the periodontitis. All the subjects, irrespective of their group assignment will undergo intensive scaling and root planing (S&RP). The supplements will be replenished, compliance will be assessed, and subjects will be examined for any potential side effects.
Another fasting blood draw, BP measurement and PWV will be performed approximately 24 hours after the S&RP. Also, the investigators will collect saliva sample during this visit.
At visit 4: at 12-week follow up, the procedure in this visit are similar to the visit 2.
At visit 5: at 16-week follow up, a post-test evaluation of vitamin D status, cardiovascular phenotypes and periodontitis will be done at the end of the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02337257
|Contact: Yanbin Dong, PhDfirstname.lastname@example.org|
|United States, Georgia|
|Georgia Prevention Institute||Recruiting|
|Augusta, Georgia, United States, 30912|
|Contact: Anas Raed 706-721-1764|
|Principal Investigator: Yanbin Dong, MD, PhD|
|Principal Investigator:||Yanbin Dong, PhD||Augusta University|