CLINICAL TRIAL: VITAMIN D PILOT (RTRN)

临床试验：维生素 D 试点 (RTRN)

• 批准号: 8173593
• 负责人: David Martins
• 金额: $ 8.36万
• 依托单位: CHARLES R. DREW UNIVERSITY OF MED & SCI
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8173593
• 关键词: Adult; African American; Blood Pressure; Blood Vessels; Cardiovascular Diseases; Cardiovascular system; Cause of Death; Cholecalciferol; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Diabetes Mellitus; Disease; Dose; Event; Functional disorder; Funding; Grant; Human; Hypertension; Institution; Intervention; Knowledge; Lead; Link; Mediator of activation protein; Metabolic Pathway; Molecular; Outcome; Overweight; Pathway interactions; Placebo Control; Placebos; Population; Population Heterogeneity; Positioning Attribute; Public Health; Randomized; Research; Research Personnel; Resources; Source; Subgroup; Therapeutic; Therapeutic Agents; Therapeutic Effect; Translating; United States National Institutes of Health; Vitamin D; Vitamin Deficiency; Vitamins; Work; cardiovascular risk factor; ethnic minority population; evidence base; mortality; pilot trial

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Cardiovascular Disease (CVD) and related disorders remain the leading cause of death in the nation1. Hypovitaminosis D has been linked not only to several cardiovascular (CV) risk factors including hypertension, diabetes, obesity2,3, but also to increased rates of CVD4,5,6. Thus, hypovitaminosis D presents a common pathway for a select subgroup with a clustering of CV risk factors in a profile that is predominant among ethnic minorities. Indeed, hypovitaminosis D is highly prevalent with an estimated 55% of the US adult population having levels at or below 30 ng/ml, and over 80% of African Americans having suboptimal values.7 A large body of evidence supports the premise that therapeutic agents that have salutary effects on vascular function, often translate into therapeutic benefits on 'harder' clinical endpoints such as adverse CV events and mortality. Exploring the potential vascular effects of vitamin D repletion presents a unique opportunity to examine both clinical outcomes and specific mechanistic pathways of a potentially modifiable intervention that could result in significant impact at a public health level. Thus, we propose a twelve week randomized doubleblind, placebo controlled pilot trial to assess the effect on vascular function and CV risk factors of 100,000 IU Vitamin D3 given every 4 weeks to overweight, hypertensive African-Americans with hypovitaminosis D. To our knowledge, the proposed project is the first to assess the effect of 'high-dose' Vitamin D3 administration on vascular function. We believe this study is also the first to examine the impact at a molecular level of Vitamin D3 repletion on the key mediators of cardio-metabolic pathways in humans. If our study results support our working hypothesis, we will be positioned to propose a larger scale study to detect a therapeutic effect on more definitive, clinical cardiovascular endpoints across a more diverse population. Hypothesis: Hypovitaminosis D activates select vasconstrictive and hypertrophic mediators that lead to endothelial dysfunction, elevated blood pressure and CVD; and Vitamin D3 repletion (using evidenced-based repletion strategies), in comparison to placebo, will ameliorate these abnormalities.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 心血管疾病（CVD）和相关疾病仍然是国家死亡的主要原因。次生氨基症D不仅与多种心血管危险因素有关，包括高血压，糖尿病，肥胖症2,3，而且与CVD4,5,6的增加相关。因此，次动蛋白病d提出了一个常见 在少数族裔中占主导地位的个人资料中，具有CV风险因素聚类的精选子组的途径。实际上，次生胺病D高度普遍，估计有55％的美国成年人口水平或低于30 ng/ml，超过80％的非洲裔美国人具有次优的价值。7 大量证据支持这样的前提：对血管功能产生有益作用的治疗剂通常会转化为“较硬”临床终点（例如不良CV事件和死亡率）的治疗益处。探索维生素D的潜在血管作用，这是一个独特的机会 检查潜在的可修改干预措施的临床结果和特定机械途径，这可能会在公共卫生水平上产生重大影响。因此，我们提出了一个十二周的随机双盲，安慰剂控制的试验试验，以评估对100,000 IU的血管功能和简历危险因素的影响 维生素D3每4周给予一次超重，高血压的非裔美国人患有次生氨基胺病。据我们所知，拟议的项目是第一个评估“高剂量”维生素D3给药对血管功能的影响的项目。我们认为，这项研究也是第一个检查维生素D3补充分子水平对人类心脏代谢途径的主要介体的影响的影响。如果我们的研究结果支持我们的工作假设，我们将提出一项大规模研究，以检测对更多样化人群中更确定的临床心血管终点的治疗作用。 假设：次生症D激活了导致内皮功能障碍，血压升高和CVD的精选血管收缩和肥厚的介质；与安慰剂相比，维生素D3的补充（使用基于证据的补充策略）将改善这些异常。