Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans With Periodontal Disease (GumD)
Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 第一阶段早期
联系人和位置
学习地点
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Georgia
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Augusta、Georgia、美国、30912
- 招聘中
- Georgia Prevention Institute
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接触:
- Anas Raed
- 电话号码:706-721-1764
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not meeting any of the above
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:cholecalciferol
Subjects will take 4000 IU per day for 30 days
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subjects will receive one pill per day which contains 4000 IU/d for 16 weeks
其他名称:
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安慰剂比较:Placebo
Subjects will take placebo everyday for 30 days
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subjects will receive placebo one pill per day for 16 weeks
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in Periodontal Disease Activity
大体时间:Baseline, 8 Weeks, 16 weeks.
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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
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Baseline, 8 Weeks, 16 weeks.
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Change in Cardiometabolic Risk Factors
大体时间:Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.
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Cardiometabolic risk factors will be measured by pulse wave velocity, central and peripheral blood pressure and glycated hemoglobin (A1C)
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Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Blood Myeloid Dendritic Cells
大体时间:Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.
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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.
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Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.
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合作者和调查者
调查人员
- 首席研究员:Yanbin Dong, PhD、Augusta University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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