Vitamin D Supplementation and Metabolism in Vitamin D Deficient Elderly (VitD)
2014年9月4日 更新者:Andrew P. Goldberg、Baltimore VA Medical Center
Effects of Vitamin D Supplementation With and With Out Exercise on Metabolic and Physical Consequences of Vitamin D Deficiency in the Elderly
The purpose of this study is to examine the effects of Vitamin D supplementation on the reasons (mechanisms) underlying the development of type 2 diabetes, metabolic syndrome (high blood pressure, cholesterol, diabetes, body weight/obesity), muscle weakness and wasting (sarcopenia), and impaired physical function (poor balance and walking) associated with vitamin D deficiency and osteopenia/osteoporosis (bone loss).
The investigators obtain vitamin D through our diet and sunlight, and its conversion to active vitamins in the liver and kidneys promotes the intestinal absorption of calcium and regulation of bone growth.
Therefore, vitamin D deficiency has been known for years to lead to weakened bones (osteopenia and osteoporosis).
However, more recently, studies show vitamin D deficiency is associated with a number of other diseases, including type 2 diabetes, muscle weakness, frailty, and the metabolic syndrome.
It has also been associated with cognitive impairment.
Diabetes affects multiple organ systems including the heart, kidneys, musculoskeletal and nervous system.
The possibility that vitamin D deficiency is linked to the development of type 2 diabetes, metabolic syndrome, muscle weakness and wasting (sarcopenia) and osteopenia/osteoporosis, and that vitamin D supplementation decreases the risk for these diseases, provides a relatively easy/accessible and inexpensive model of preventive therapy to decrease the incidence of these diseases.
In addition, it is likely that genetic (inherited) factors play a role, but the relationship of these genes to these metabolic abnormalities have not been elucidated.
Understanding the role of Vitamin D in health will allow us to translate these findings into therapy.
研究概览
地位
终止
研究类型
介入性
注册 (实际的)
39
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Maryland
-
Baltimore、Maryland、美国、21201
- Baltimore VAMC
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 85年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 40-85 years of age
- Women must be post menopausal (absence of menses for 12 months or greater)
- 25-hydroxyvitamin D level below 20 ng/ml (50 nmol/L)
- BMI 25-45 kg/m2
- Non smoker ( non smoking for at least 12 months:cigarettes, cigars, pipes)
Exclusion Criteria:
- Symptomatic heart disease, CAD, CHF, or uncontrolled hypertension (BP over 180 mm HG) unless medically stabilized
- Currently being treated for active cancer
- Type 1 diabetes; insulin treatment for diabetes, poorly controlled diabetes, HgA1c >10%
- Allergic to lidocaine
- History of seizures or taking anti-seizure or anti convulsion medications
- Untreated dyslipidemia with National Cholesterol ATPIII 10 year cardiac risk score greater than 10% (www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.htm)
- Taking oral steroids, warfarin or other medications interfering with fat/muscle metabolism that may not be safely discontinued temporarily for specific procedures (ie for 72 hours prior)
- Taking medication that interfere with ability to replete Vitamin D
- Abnormal liver function 2 times normal levels
- Abnormal renal function (BUN above 40 mg/dl, Cr above 1.8 mg/dl, CrCl<60mg/dl)
- Hypercalcemia (Ca>10.2mg/dl)
- Anemia HCT below 30 mg/dl, platelets below 100,000/cm3
- Chronic pulmonary disease (on supplemental O2)
- Other systemic disorders that are not medically treated and stable or affect the ability to absorb Vitamin D.
- MMSE below 24, dementia or unstable clinical depression by exam
- Abnormal response to exercise test (ST segment depression greater than 2mm, chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising BP above 240/120 mm HG, or other contraindications to exercise) *requires follow up treatment w/ primary MD for continued participation in study
- Aerobically trained with VO2max greater than 2 SD above age-adjusted mean
- Participant is, in the opinion of the investigator, unable to adhere to the study protocol due to medical or orthopedic conditions that limit ability to exercise or travel to the Baltimore VA for protocol procedures.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:RDA Vitamin D
|
800 IU of Vitamin D3 daily for 6 months
其他名称:
|
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实验性的:Vit D repletion + 6M Supplementation
|
Vitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily
其他名称:
|
|
实验性的:Vit D repletion + 6M Supplementation +AEX
|
Vitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily plus aerobic exercise training
其他名称:
|
|
实验性的:Vit D repletion + 6M Supplementation +RT
|
Vitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily plus resistance training
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
glucose tolerance and insulin sensitivity
大体时间:Baseline, 3 months and 6 months
|
Baseline, 3 months and 6 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
muscle structure, inflammation and metabolic function to cause sarcopenia and frailty
大体时间:Baseline, 3 months and 6 months
|
Baseline, 3 months and 6 months
|
|
physical performance, balance and strength to increase strength and balance to reduce fall risk in older people
大体时间:Baseline, 3 months and 6 months
|
Baseline, 3 months and 6 months
|
|
cognitive function
大体时间:Baseline, 3 months and 6 months
|
Baseline, 3 months and 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Andrew P Goldberg, M.D.、Baltimore VAMC/GRECC
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年5月1日
初级完成 (实际的)
2013年2月1日
研究完成 (实际的)
2013年2月1日
研究注册日期
首次提交
2010年6月16日
首先提交符合 QC 标准的
2010年6月16日
首次发布 (估计)
2010年6月17日
研究记录更新
最后更新发布 (估计)
2014年9月5日
上次提交的符合 QC 标准的更新
2014年9月4日
最后验证
2014年9月1日
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.