Randomized trial of vitamin D and omega-3 fatty acids for diabetic kidney disease

 描述(由申请人提供)：在本申请中，我们申请竞争性续期资助维生素D和欧米茄-3预防和治疗糖尿病肾脏疾病(VITAL-DKD)试验。在我们最初的资助期间，我们推出了VITAL-DKD，作为父母维生素D和Omega-3试验(VITAL)的辅助研究。具体地说，对于大型(N=25,875)和单亲重要试验，我们将肾脏结果和伴随的临床数据添加到1322名患有流行的2型糖尿病的重要参与者的子集中，以测试维生素D3和omega-3脂肪酸对DKD临床表现的影响。在这一竞争性续签申请中，我们建议将我们重要的DKD辅助研究的随访时间从2年延长至5年，增加对存储标本的测量，以更全面地评估治疗效果，并评估与我们的主要肾脏结果相辅相成的中间心血管结果。我们的方法建立在我们招募的研究人群和完成的测量基础上，并利用父母重要试验的基础设施，该试验由美国国立卫生研究院资助，到2017年提供研究治疗和基本数据获取。我们招募了不同的研究人群，他们患有或存在DKD风险，并保持对研究药物的良好依从性。为了扩展我们的研究，我们经验丰富的研究团队将应用在我们最初的资助期间开发并成功实施的方法。初步数据表明，保留率和依从率很高，实验室方案也很成功。我们预计，本文建议的额外研究，加上最初资助期的研究，将对维生素D3和omega-3脂肪酸对DKD的长期影响进行全面评估。

 DESCRIPTION (provided by applicant): In this application, we apply for a competitive renewal of the grant that funds the Vitamin D and Omega-3 Trial to prevent and treat Diabetic Kidney Disease (VITAL-DKD). During our initial period of funding, we launched VITAL-DKD as an ancillary study to the parent Vitamin D and Omega-3 Trial (VITAL). Specifically, to the large (N=25,875) and simple parent VITAL trial, we added kidney outcomes and accompanying clinical data to a subset of 1,322 VITAL participants with prevalent type 2 diabetes to test the effects of vitamin D3 and omega-3 fatty acids on the clinical manifestations of DKD. In this competitive renewal application, we propose to extend follow-up of our VITAL DKD ancillary study from 2 to 5 years, add measurements to stored specimens to more comprehensively evaluate treatment effects, and assess intermediate cardiovascular outcomes that complement our primary renal outcome. Our approach builds on our recruited study population and completed measurements and leverages the infrastructure of the parent VITAL trial, which is funded by the NIH to provide study treatments and basic data acquisition through 2017. We have recruited a diverse study population with type 2 diabetes that has or is at risk of DKD and is maintaining excellent adherence to study medications. To extend our study, our experienced study team will apply methods developed and successfully implemented during our initial funding period. Preliminary data demonstrate high retention and adherence rates and successful laboratory protocols. We anticipate that the additional studies proposed herein, when added to those of the initial funding period, will generate a comprehensive evaluation of the long-term effects of vitamin D3 and omega-3 fatty acids on DKD.