Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives

维生素 D 和鱼油对高血压患者肾脏的影响

基本信息

批准号：
9284458
负责人：
Michal L Melamed
金额：
$ 75.64万
依托单位：
ALBERT EINSTEIN COLLEGE OF MEDICINE, INC
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-01 至 2020-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9284458
关键词：
25-hydroxyvitamin D Affect African American Albumins Albuminuria American Anabolism Animals Anti-Inflammatory Agents Anti-inflammatory Antihypertensive Agents Biological Assay Blood Blood Pressure Blood specimen Calcitriol Calcium Cardiovascular Diseases Cardiovascular system Cholecalciferol Clinical Clinical Trials Clinical Trials Design Collection Creatinine Data Development Diabetes Mellitus Dialysis procedure Dihydroxycholecalciferols Disease Disease Outcome Disease Progression Docosahexaenoic Acids Dose Eicosapentaenoic Acid End stage renal failure Event Fibroblast Growth Factor Fish Oils Functional disorder Funding General Population Glomerular Filtration Rate Gray unit of radiation dose Human Hypertension IGA Glomerulonephritis Incidence Individual Industry Kidney Kidney Diseases Lead Malignant Neoplasms Measures Morbidity - disease rate Observational Study Older Population Omega-3 Fatty Acids Outcome PTH gene Parents Participant Patients Placebo Control Placebos Prevention Randomized Randomized Clinical Trials Randomized Controlled Clinical Trials Recommendation Renal function Renin Research Infrastructure Research Personnel Resources Risk Risk Factors Sampling Serum Supplementation Testing Time United States National Institutes of Health Urine Vitamin D Woman clinically relevant cost effective cost efficient design dietary supplements ethnic minority population evidence base follow-up health care service utilization high risk kidney preservation men mortality nephrogenesis older men older women outcome forecast post gamma-globulins prevent public health relevance racial minority randomized placebo controlled trial randomized trial study population urinary

项目摘要

DESCRIPTION (provided by applicant): There are 26 million Americans living with kidney disease and 66 million Americans living with hypertension, the second most common cause of end-stage kidney disease requiring dialysis. Kidney disease is associated with a significantly increased risk of morbidity and mortality even before reaching end-stage kidney disease. Animal studies and observational studies in humans, including studies by investigators leading this proposed study, suggest that vitamin D and omega-3 fatty acids may be protective against kidney disease. Despite the evidence base available, there is still no definitive study testing the effects of these relatively safe nutritional supplements on kidney disease progression in humans. We now have an opportunity to provide such data in a highly feasible and cost-efficient manner. We propose to take advantage of the VITamin D and OmegA-3 TriaL (VITAL) trial to test whether vitamin D3 (at a dose of 2,000 IU/day) or omega-3 fatty acids (eicosapentaenoic acid plus docosahexaenoic acid, 1 gm/day) will preserve kidney function, as measured by serum creatinine and cystatin C, over a 4 year period. The VITAL trial is an NIH funded, placebo-controlled clinical trial randomizing 25,875 participants (men older than 50 and women older than 55 years) in a 2x2 factorial design to vitamin D3 versus placebo and omega-3 fatty acids versus placebo for 5 years to evaluate effects on cardiovascular disease and cancer events. The VITAL trial is not currently planning to evaluate kidney function in participants with hypertension. We, therefore, propose to measure serum creatinine and cystatin C and urinary albumin and creatinine at year 4 post-randomization in 4000 participants of the VITAL trial who at baseline have hypertension, no diabetes mellitus, are older than 60 years and have pre-randomization blood samples available collected by the parent study. We estimate that with these entry criteria, 25% of our 4000 patients will have an eGFR <60 ml/min/1.73m2 and 25% will be ethnic and racial minorities. We will evaluate changes in estimated GFR calculated by serum creatinine and cystatin C levels over a 4 year period, the incidence of end-stage renal disease, prevalent albuminuria at year 4 and parathyroid hormone, calcium and FGF-23 levels at baseline and year 4 in the subset with eGFR <60 ml/min/1.73m2. The proposed study takes advantage of the infrastructure and design of the VITAL trial to provide much needed data about the effects of vitamin D3 and omega-3 fatty acids on the kidney.

描述（由适用提供）：有2600万美国人患有肾脏疾病，有6600万美国人患有高血压，这是终末期肾脏疾病的第二常见原因，需要透析。肾脏疾病甚至在达到末期肾脏疾病之前就与发病率和死亡率的风险显着增加有关。动物研究和人类的观察性研究，包括领导这项拟议研究的研究者的研究，表明维生素D和omega-3脂肪酸可能受到肾脏疾病的保护。尽管有证据库，但仍未有确切的研究测试这些相对安全的营养补充剂对人类肾脏疾病进展的影响。现在，我们有机会以高度可行且具有成本效益的方式提供此类数据。 We propose to take advantage of the VITamine D and OmegA-3 TriaL (VITAL) trial to test whether vitamin D3 (at a dose of 2,000 IU/day) or omega-3 fatty acids (eicosapentaenoic acid plus docosahexaenoic acid, 1 gm/day) will preserve kidney function, as measured by serum creatinine and cystatin C, over a 4 year period.这项重要试验是一项由NIH资助的，安慰剂对照的临床试验，在2x2析因设计中，与维生素D3相对于安慰剂和omega-3脂肪酸与安慰剂相对于安慰剂，在5年中随机对25,875名参与者（超过50岁的男性和55岁以上的女性），以评估对心血管疾病和癌症事件的影响。重要的试验目前尚未计划评估高血压参与者的肾功能。因此，我们建议在4000名重要试验的参与者中测量4000名参与者的血清Crectionine和Cystatin C以及尿中蛋白和Crectioninine，他们在基线时患有高血压，没有糖尿病，没有60岁以上，并且具有父母研究可获得的前随身携带的血液样本。我们估计，有了这些进入标准，我们4000名患者中有25％的EGFR <60 mL/min/min/1.73m2，而25％的患者将是种族和种族少数族裔。我们将评估4年内由血清肌酐和伴半胱氨酸蛋白酶C水平计算出的估计GFR的变化，终末期肾脏疾病的事件，4年级的蛋白尿流行和甲状旁腺激素，钙和FGF-23在基线和4年级的甲状动脉激素，钙和FGF-23水平，在EGFR <60 mL/min/min/min/min/1.733m/1.733m2中。拟议的研究利用了重要试验的基础设施和设计，提供了有关维生素D3和Omega-3脂肪酸对肾脏的影响的急需数据。