The Influence of Low Phosphorus in Hemodialysis Patients
The Influence of Low Phosphorus in Hemodialysis Patients
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.
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.

 Data Collection:

 The personal characteristics and the anthropometry data were collected at baseline. All data
 were collected at baseline, one week after the washout period, and the end of the
 7-days-study period. The indicators were including dietary contents, phosphate binder
 administration, dialysis adequacy, nutritional indicators, blood lipid indicators,
 biochemical indicators, CKD-MBDs indicators, and inflammation indicators.
Inclusion Criteria:

 -  Hemodialysis patients, ≥ 20 years of age

 Exclusion Criteria:

 -  ≥ 80 years of age, liver cirrhosis, cancer, pregnancy, vegetarian