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临床试验/NCT03649802
NCT03649802已完成2 期

Treating Vitamin D Insufficiency in Community Dwelling Elderly to Improve Arterial Stiffness

Texas Tech University Health Sciences Center2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年8月16日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
52
试验地点
2
主要终点
Heart rate variability

研究概览

简要总结

Investigators will examine arterial stiffness and pulse waveform analysis. Subjects with vitamin D insufficiency will be recruited. A double blind randomized controlled study will examine the effects of standard dose vitamin D3 (800 IU) versus higher dose vitamin D3 (5000 IU)-given on a daily basis.In order to understand mechanisms of action by which vitamin D would improve arterial stiffness investigators will use biomarkers. Oxidative and inflammatory stress will be measured by plasma F2-isoprostanes and Sulforaphane levels.

详细描述

Cardiovascular disease disproportionately impacts the elderly. Current practice targets vascular disease with aggressive lipid lowering combined with brachial BP regulation, but has only achieved a modest degree of success. There is a need to intervene at a much earlier stage. Increased arterial stiffness is a marker for subclinical vascular disease and a sensitive predictor of ischemic stroke in the elderly. Vitamin D deficiency is linked to an increased risk of vascular disease.

There is an urgent need for well controlled randomized interventional studies in healthy elderly individuals demonstrating that vitamin D levels can improve vascular function in healthy elderly with vitamin D insufficiency. High dose vitamin D (5000 IU) replacement is required to improve systemic inflammation which may contribute to arterial stiffness and vascular aging.

The hypothesis is that daily 5000 IU vitamin D3 will regress or at least prevent progression of arterial stiffness as assessed by the carotid-femoral pulse wave velocity. Furthermore, investigators postulate that this improvement will be linked to improved oxidative and inflammatory status. Investigators will measure plasma measurements of Sulforaphane and plasma F2-isoprostane to assess the anti-oxidative mechanisms by which vitamin D could influence arterial stiffness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

The study coordinators will be aware of the allocation into the low and high dose vitamin D groups but the patient and the investigators will be blinded from this information.

入排标准

年龄范围
65 Years 至 89 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Community dwelling adults (Subjects) aged between 65 and 89 years of age
  • Subjects should be ambulatory, living at home and capable of self-care
  • Subjects should be able to drive an automobile independently and without assistance
  • Subjects agree to home visitation by coordinators to assess pill counts or willing to come to TTUHSC for such a visit every 4 weeks ± 3 days
  • 25(OH) Vitamin D value < 30 ng/ml
  • Subjects able to read and understand the English language

排除标准

  • Subjects unable or unwilling to have follow up for the duration of the study
  • Subjects that cannot take a daily Vitamin D supplement or unwilling to have multiple blood draws
  • Subjects on peritoneal or hemodialysis or a life expectancy less than 2 years
  • Subjects with Sarcoidosis or diseases associated with hypercalcemia
  • Subjects with prior cerebrovascular disease or memory problems
  • Subjects with prior myocardial infarction or atrial fibrillation or on anticoagulants
  • Subjects on medications for memory or cognitive issues or mental health
  • Subjects unable to tolerate Sphygamocor and Complior testing protocol

结局指标

主要结局

Heart rate variability

时间窗: 1 year

Using postural changes to assess heart rate variability in beats per minute using Sphygmacor

Carotid-femoral pulse wave velocity measured by equipment provided by Complior pulse wave analysis

时间窗: 1 year

Indicator of arterial stiffness meters per second

24 hour BP ambulatory monitoring

时间窗: 1 year

Using Central and Brachial BP in mm Hg determination using Sphygmacor

次要结局

  • Plasma sulphoraphane and F2-isoprostanes. Isoprostanes will be measured by gas chromatography mass spectrometry and sulphoraphane will be measured using LC-MS/MS techniques(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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