Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Periodontal Disease Activity
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •You are African American
- •You have generalized chronic moderate to severe gum disease (periodontitis)
- •Your age is between 18-60 years.
- •You are not taking any vitamin, mineral or herbal supplements
- •If you are a female, you are not pregnant
排除标准
- •Not meeting any of the above
研究组 & 干预措施
cholecalciferol
Subjects will take 4000 IU per day for 30 days
干预措施: Cholecalciferol (Drug)
Placebo
Subjects will take placebo everyday for 30 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Periodontal Disease Activity
时间窗: 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
时间窗: 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)
次要结局
- Change in Blood Myeloid Dendritic Cells(Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.)
