Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 and Normal Protein Diet Virus Low Protein Diet in the Treatment of CKD-MBD and Malnutrition for Progressive CKD Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 36 months
研究概览
简要总结
Multi-center, prospective, randomized, controlled study to verify the clinical effectiveness of K / DOQI guidelines. The efficiency and safety of Vitamin D2 and low protein diet treatment for prevention and treatment of CKD-MBD and malnutrition in CKD3-5 (ND) patients.
详细描述
This study will enroll chronic kidney disease patients, stage 3 to 5ND, who have chronic kidney disease mineral and bone disease (CKD-MBD) and malnutrition as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in five centers will be randomized. A total of 600 patients will be enrolled, 150 patients receiving Vitamin D2 treatment virus 150 patients receiving calcitriol treatment, and another 150 patients receiving low protein diet virus 150 patients receiving normal protein diet. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, 25 hydroxyvitamin D, albumin and hemoglobin. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, cardiovascular diseases, nutritional status and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age between 18-80 years.
- •Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder and malnutrition
排除标准
- •Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
- •Active system immunity diseases.
- •History of liver failure
- •History of intestinal malabsorption or chronic diarrhea
- •Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
- •Primary hyperparathyroidism
- •Treatment with cinacalcet or other calcimimetic within the past 6 months
- •Anticipated dialysis within 6 months after randomization
- •Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator
- •Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s).
- •Current treatment with vitamin D 50,000 IU
- •Using glucocorticoid or immunosuppressive agents.
- •Acute renal dysfunction.
- •The expected live time is less than 2 years.
- •Pregnant or lactating woman.
- •Suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
- •Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
研究组 & 干预措施
Vitamin D2 Treatment
干预措施: Vitamin D2 (Drug)
1,25(OH)2 Vitamin D3
干预措施: 1,25(OH)2 Vitamin D3 (Drug)
low protein diet
干预措施: low protein diet (Dietary Supplement)
normal protein diet
干预措施: normal protein diet (Dietary Supplement)
结局指标
主要结局
The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 36 months
时间窗: 36 months
The blood levels of calcium, phosphorus,and intact parathyroid (iPTH) will be detected every three months. The values during follow-up will be compared to the baseline.
The changes on the clinical indicators of nutritional status
时间窗: 36 months
The blood levels of albumin, prealbumin, transferrin and hemoglobin will be detected every three months. The values during follow-up will be compared to the baseline.
次要结局
- The changes of the blood 25(OH)Vitamin D level(36 months)
- The changes of the quality of life(36 months)
研究者
Wenhu Liu
Professor
Beijing Friendship Hospital