The Influence of Low Phosphorus Meals on Serum Phosphorus Concentration and Inflammatory Indicators in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- blood pressure
研究概览
简要总结
Consuming high levels of dietary phosphate and poor adherence of phosphate-binding-therapy might induce hyperphosphatemia in the hemodialysis (HD) patients. Therefore, the risks of Chronic Kidney Disease-related Mineral and Bone Disorders (CKD-MBDs) and inflammation will be increased. This double blind and intervention randomized controlled trial study will be designed to investigate the hypothesis that if low phosphorus meals decrease serum phosphorus concentration and inflammatory indicators. A total of 80 HD patients in the HD center of Shuang Ho Hospital will be recruited and be assigned to low phosphorus meal group (LP group) and control group randomly before one-week-washout period. The subjects of LP group and control group will consume low phosphorus meals and standard meals respectively. During washout period and study period, all subjects will continue to consume their regular breakfast and take one tablet of calcium carbonate with meal. All data will be collected at baseline, one week after the washout period, and the end of the 7-days-study period. The indicators are including dietary contents, phosphate binder administration, indicators of dialysis adequacy, nutritional indicators, blood lipid indicators, biochemical indicators, CKD-MBDs indicators, and inflammation indicators. Data were analyzed by Statistical Product and Service Solutions program version 18. Paired t-test, Student's t-test, Pearson correlation coefficient and Logistic regression will be used. P < 0.05 will be considered as statistically significant.
详细描述
Study Design and Subjects:
This study was design as a randomized, double-blind control trail. A total of 80 HD patients were recruited from the HD center of Taipei Medical University-Shuang Ho Hospital in Taiwan. The inclusion criteria were including ≧20 years old and non vegetarian. The exclusion criteria are including liver dysfunction, cancer and pregnancy.
Dietary Intervention:
All subjects followed their usual diets but took one tablet of calcium carbonate as phosphate binder per meal for the first week washout diet. After washout diet, subjects were assign to control or study group randomly and entered to the study period for one week. The diets of the study group were low phosphorus ( LP group), but the dietary phosphorous levels of the control group were not modified. During the study period, all subjects including LP group and control group still kept their usually accustomed behavior about regular breakfast and also took one tablet of calcium carbonate as phosphate binder with every breakfast meal. The LP group and control group replaced daily lunch and dinner with low phosphorus and standard meals respectively and should not take any phosphate binder during the study period for one week.
For controlling the volumes of proteins, phosphorus and calcium easily, the main courses of both of the study and the control meals were made by a central kitchen. All of the meals contained 3 exchanges of protein (25 g) and 1 exchange of vegetable. There were 5 main courses for the both diets. The proteins of the study meals had been removed by an average 20 -30% of the phosphorus through boiling the meats before cooking process. But the boiling method did not process for the control meals. Every meal including all the study and the control meals contained one tablet of calcium carbonate. As a consequence, the additional phosphate binders should not be taken while eating the study meals. The subjects had to prepare carbohydrate by themselves, and they could choose any source of carbohydrate as their wants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodialysis patients, ≥ 20 years of age
排除标准
- •≥ 80 years of age, liver cirrhosis, cancer, pregnancy, vegetarian
结局指标
主要结局
blood pressure
时间窗: the end of the 7-days-study period
systolic blood pressure (mmHg), diastolic blood pressure (mmHg)
dietary contents
时间窗: the end of the 7-days-study period
24-hour dietary recall
blood lipid indicators
时间窗: the end of the 7-days-study period
LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)
phosphate binder administration
时间窗: the end of the 7-days-study period
type and dosing frequency
indicators of dialysis adequacy
时间窗: the end of the 7-days-study period
Kt/V
anthropometric measurement
时间窗: the end of the 7-days-study period
body height (cm)
biochemical indicators
时间窗: the end of the 7-days-study period
normalized protein equivalent of total nitrogen appearance(g/kg/d)
inflammation indicators
时间窗: the end of the 7-days-study period
C reactive protein (mg/dL)
Electrolyte
时间窗: the end of the 7-days-study period
P(mg/dL), Ca(mg/dL), Mg(mg/dL)
次要结局
未报告次要终点