MODIFICATION OF DIET IN RENAL DISEASE STUDY

临床和实验数据表明，进行性病程 慢性肾脏疾病的情况可以通过限制有利地改变 蛋白质和磷的饮食摄入量。因此， 美国国立卫生研究院为该合作社提供赞助 进展性食管炎患者饮食调理的临床研究 肾脏疾病(MDRD)来验证这一假说。具体目标 这项研究的三个方面： 1.比较和研究低蛋白饮食的疗效 和磷限制，一种非常低蛋白质的饮食 补充剂和磷酸盐限制，以及适度的饮食 蛋白质摄入量与磷限制在肥胖过程中的作用 进行性慢性肾功能不全。 2.确定患者对这些饮食干预措施的接受程度。 3.评价营养安全性和营养等 这些不同饮食干预措施的效果。 要纳入研究，患者必须在18-75岁之间 其GFR一般范围为10-80毫升/分钟/1.73平方米。 排除标准包括怀孕、不良医疗病史 依从性、体重异常、低蛋白血症、蛋白尿 超过10克/24小时，未控制的高血压，胰岛素 需要糖尿病，恶性肿瘤，严重的心力衰竭， 慢性肝肺疾病、全身性感染、活动性 胶原蛋白血管疾病、尿潴留和过敏 硫代氨基甲酸盐或碘。 入选这项研究的患者将接受广泛的饮食和 营养评估和肾功能测量。之后 三个月的基准期患者被随机分配到特定的 饮食方案，每月至少跟踪15次 月份。营养和肾功能将被仔细监测。 根据对肾脏营养状况的评估，几次“停” 功能和一般医疗条件，被内置到协议中 以确保病人的安全。

Clinical and experimental data suggest that the progressive course of chronic renal disease may be altered favorably by restriction of the dietary intake of both protein and phosphorus. Therefore, the National Institutes of Health is sponsoring the Cooperative Clinical Study of Dietary Modification on the Course of Progressive Renal disease (MDRD) to test this hypothesis. The specific aims of the study are three-fold: 1. To compare and investigate the efficacy of a low-protein diet and phosphorus restriction, a very low protein diet with dietary supplements and phosphate restriction, and a diet with moderate protein intake and phosphorus restriction on the course of progressive chronic renal insufficiency. 2. To determine patient acceptance of these dietary interventions. 3. To evaluate the nutritional safety and nutritional and other effects of these various dietary interventions. To be included in the study patients must be 18-75 years of age with their GFR in the general range of 10-80 ml/min/1.73 m2. Exclusion criteria include pregnancy, history of poor medical compliance, abnormal body weight, hypoalbuminemia, proteinuria greater than 10 grams/24 hours, uncontrolled hypertension, insulin requiring diabetes mellitus, malignancy, severe heart failure, chronic liver and lung disease, systemic infections, active collagen vascular disease, urinary retention and allergy to iothalamate or iodine. Patients selected for the study will undergo extensive diet and nutritional evaluation, and measurement of renal function. After a three-month baseline period patients are randomized to a specific dietary regimen and followed monthly for a minimum period of 15 months. Nutrition and renal function will be monitored carefully. Several "stop" based on evaluation of nutritional status, renal function and general medical condition, are built into the protocol to insure patient safety.