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临床试验/NCT02337257
NCT02337257Unknown早期 1 期

Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans

Augusta University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

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:

  1. Group 1 who will receive placebo.
  2. 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

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

Active Comparator

Subjects will take 4000 IU per day for 30 days

干预措施: Cholecalciferol (Drug)

Placebo

Placebo Comparator

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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanbin Dong

Professor

Augusta University

研究点 (1)

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