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临床试验/NCT01145703
NCT01145703终止不适用

Effects of Vitamin D Supplementation With and With Out Exercise on Metabolic and Physical Consequences of Vitamin D Deficiency in the Elderly

Baltimore VA Medical Center1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2010年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
39
试验地点
1
主要终点
glucose tolerance and insulin sensitivity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

研究组 & 干预措施

Vit D repletion + 6M Supplementation +AEX

Experimental

干预措施: Vitamin D2/3 Repletion + AEX (Other)

Vit D repletion + 6M Supplementation +RT

Experimental

干预措施: Vitamin D2/3 Repletion + RT (Other)

Vit D repletion + 6M Supplementation

Experimental

干预措施: Vitamin D2/3 Repletion only (Dietary Supplement)

RDA Vitamin D

Active Comparator

干预措施: RDA Vitamin D3 only (Dietary Supplement)

结局指标

主要结局

glucose tolerance and insulin sensitivity

时间窗: Baseline, 3 months and 6 months

次要结局

  • physical performance, balance and strength to increase strength and balance to reduce fall risk in older people(Baseline, 3 months and 6 months)
  • muscle structure, inflammation and metabolic function to cause sarcopenia and frailty(Baseline, 3 months and 6 months)
  • cognitive function(Baseline, 3 months and 6 months)

研究者

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

Andrew P. Goldberg

GRECC Director, Professor of Medicine

Baltimore VA Medical Center

研究点 (1)

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