MODIFICATION OF DIET IN RENAL DISEASE STUDY

临床和实验数据表明， 慢性肾脏疾病的发病率可以通过限制 蛋白质和磷的饮食摄入量。 因此，我们认为， 美国国立卫生研究院赞助了 饮食调整对进展期胃癌的临床研究 肾脏疾病（MDRD）来检验这一假设。 具体目标 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，一个非常低的蛋白质饮食， 补充剂和磷酸盐限制，以及适度的饮食 蛋白质摄入和磷限制的过程中， 进行性慢性肾功能不全 2. 确定患者对这些饮食干预的接受程度。 3. 评价其营养安全性和营养及其他 这些不同的饮食干预的影响。 入组研究的患者年龄必须为18-75岁 其GFR通常在10-80 ml/min/1.73 m2的范围内。 排除标准包括妊娠、不良医疗史、 依从性、体重异常、低白蛋白血症、蛋白尿 大于10克/24小时，不受控制的高血压，胰岛素 需要糖尿病、恶性肿瘤、严重心力衰竭， 慢性肝病和肺病，全身感染，活动性 胶原血管疾病、尿潴留和过敏 碘酞酸盐或碘。 入选研究的患者将接受广泛的饮食， 营养评估和肾功能测量。 后 在三个月的基线期内，患者被随机分配到一个特定的 饮食方案，每月随访至少15 个月 营养和肾功能将受到密切监测。 几个“停”的基础上评估营养状况，肾 功能和一般医疗状况，都内置到协议中 以确保患者安全。

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.