Comparison of the Effects Between Keto-/Amino Acid Supplemented Low Protein Diet and Non-Supplemented Low Protein Diet in Patients With Stage Ⅴ Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 主要终点
- Glomerular filtration rate (GFR) and creatinine clearance (Ccr)
研究概览
简要总结
Keto-/amino acid supplemented low protein diet can reduce uremic symptoms, improve nutritional status, delay dialysis therapy and enhance health-related quality of life in our patients with stage V CKD in comparison to non-supplemented low protein diet.
详细描述
Fifty patients will be included into the study. The study comprises 9 visits. The treatment period covers 6 months, preceded by a 2-week screening period and a 1 month run-in period. Patients are required to visit the investigator two times before the start of active treatment.
All patients who are qualified for this study will then be randomised by receiving their medication/introduction of dietary management using the standard simple randomization method.Group I patients will receive keto-/amino acid (Ketosteril) supplemented low protein diet during the active treatment period while Group II patients will receive non-supplemented low protein diet during the same period. The daily dose of keto-/amino acid for each Group I patient is one tablet every 5 kg body weight. The total daily dose will be divided into three times a day.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serum creatinine ≧6 mg/dl at Visit
- •Creatinine clearance < 15 ml/min at Visit
- •Urine output ≧ 1,000 ml/day
- •Primary renal disease: chronic glomerulonephritis or non-diabetic stage Ⅴ chronic kidney disease (confirmed by biopsy or clinical presentations/symptoms)
- •Bilaterally reduced renal size shown by sonography
- •Male or female patients aged 20 -
- •Ability of the patient to understand the basic implications of the study and to follow instructions
- •Willingness to participate as indicated by a signed written informed consent
排除标准
- •Severe arterial hypertension not responsive to medical therapy, maximum blood pressure values allowed: 180/100 mm Hg
- •Inadequate caloric intake due to extremely severe uremia (vomiting, anorexia, etc)
- •Malnutrition status with serum albumin level less than 3.5 g/dl in recent one month
- •Lack of adherence to dietary prescription
- •Water and sodium retention not responsive to diuretics
- •Clinical relevant severe cardiac disease, hepatic disorders (total bilirubin > 1.5 times the upper limit of normal), malabsorption disorders, diseases requiring steroids or non-steroid anti-inflammatory drugs
- •Severe sodium wasting syndrome that may affect renal function markedly and independently of dietary therapy
- •Concurrent use of nephrotoxic drugs
- •Severe infection with catabolic situation
- •Signs of uremic pericarditis
- •Symptoms of uremic polyneuropathy
- •Disorder of amino acid metabolism
- •Pregnant or nursing women
- •Participation in a clinical trial within the last 2 months
- •Former participation in the present study
结局指标
主要结局
Glomerular filtration rate (GFR) and creatinine clearance (Ccr)
次要结局
- 1. Hemodynamics, 2. Biochemistry status, 3. Bone density analysis, 4. Nutritional status, 5. Urinary status, 6. Compliance check, 7. Incidence of Aes8. Health-related quality of life, 9. Economic benefit