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（由申请人提供）：有 2600 万美国人患有肾脏疾病，6600 万美国人患有高血压，这是导致需要透析的终末期肾脏疾病的第二个最常见原因。肾脏疾病与发病率和患病风险显着增加有关。动物研究和人类观察性研究（包括领导这项拟议研究的研究人员的研究）表明，尽管有证据基础，维生素 D 和 omega-3 脂肪酸可能具有预防肾病的作用。目前还没有明确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我们现在有机会以可行且具有成本效益的方式提供此类数据，我们建议利用维生素 D 和 OmegA-3 TriaL (VITAL) 试验。测试维生素 D3（剂量为 2,000 IU/天）或 omega-3 脂肪酸（二十碳五烯酸加二十二碳六烯酸，1 克/天） VITAL 试验是一项 NIH 资助的安慰剂对照临床试验，随机招募了 25,875 名参与者（50 岁以上的男性和 55 岁以上的女性）。对维生素 D3 与安慰剂以及 omega-3 脂肪酸与安慰剂进行为期 5 年的 2x2 析因设计，以评估对心血管疾病和癌症事件的影响。 VITAL 试验目前不计划评估肾功能。因此，我们建议在随机分组后第 4 年对 4000 名基线时患有高血压、无糖尿病且年龄超过 60 岁的受试者进行血清肌酐和胱抑素 C 以及尿白蛋白和肌酐的测量。并拥有母研究收集的随机化前血液样本，我们估计，根据这些进入标准，我们的 4000 名患者中将有 25% 具有 eGFR。 <60 ml/min/1.73m2 和 25% 将是少数族裔和种族。我们将评估 4 年期间通过血清肌酐和胱抑素 C 水平计算的估计 GFR 的变化、终末期肾病的发生率、普遍的蛋白尿。 eGFR <60 ml/min/1.73m2 的子集中第 4 年的甲状旁腺激素、钙和 FGF-23 水平在基线和第 4 年的水平。 VITAL 试验的基础设施和设计，以提供有关维生素 D3 和 omega-3 脂肪酸对肾脏影响的急需数据。