The Influence of Low Phosphorus in Hemodialysis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Influence of Low Phosphorus Meals on Serum Phosphorus Concentration and Inflammatory Indicators in Hemodialysis Patients

Conditions
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Hemodialysis Patients

Intervention / Treatment
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* Other: low phosphorus meals
* Other: control meals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemodialysis patients, ≥ 20 years of age Exclusion Criteria: ≥ 80 years of age, liver cirrhosis, cancer, pregnancy, vegetarian

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low phosphorus meal group (LP group)<br>The proteins of the low phosphorus meal had been removed by an average 20 -30% of the phosphorus through boiling the meats before cooking process. | Other: low phosphorus meals<br>* 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.<br>|
| Placebo Comparator: control group<br>The boiling method did not process for the control meals. | Other: control meals<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometric measurement | body height (cm) | baseline | 
| anthropometric measurement | body height (cm) | one week after the washout period | 
| anthropometric measurement | body height (cm) | the end of the 7-days-study period | 
| anthropometric measurement | body weight before hemodialysis (Kg), dry weight (Kg) | baseline | 
| anthropometric measurement | body weight before hemodialysis (Kg), dry weight (Kg) | one week after the washout period | 
| anthropometric measurement | body weight before hemodialysis (Kg), dry weight (Kg) | the end of the 7-days-study period | 
| blood pressure | systolic blood pressure (mmHg), diastolic blood pressure (mmHg) | baseline | 
| blood pressure | systolic blood pressure (mmHg), diastolic blood pressure (mmHg) | one week after the washout period | 
| blood pressure | systolic blood pressure (mmHg), diastolic blood pressure (mmHg) | the end of the 7-days-study period | 
| dietary contents | 24-hour dietary recall | baseline | 
| dietary contents | 24-hour dietary recall | one week after the washout period | 
| dietary contents | 24-hour dietary recall | the end of the 7-days-study period | 
| phosphate binder administration | type and dosing frequency | baseline | 
| phosphate binder administration | type and dosing frequency | one week after the washout period | 
| phosphate binder administration | type and dosing frequency | the end of the 7-days-study period | 
| indicators of dialysis adequacy | Kt/V | baseline | 
| indicators of dialysis adequacy | Kt/V | one week after the washout period | 
| indicators of dialysis adequacy | Kt/V | the end of the 7-days-study period | 
| blood lipid indicators | LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL) | baseline | 
| blood lipid indicators | LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL) | one week after the washout period | 
| blood lipid indicators | LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL) | the end of the 7-days-study period | 
| biochemical indicators | normalized protein equivalent of total nitrogen appearance(g/kg/d) | baseline | 
| biochemical indicators | normalized protein equivalent of total nitrogen appearance(g/kg/d) | one week after the washout period | 
| biochemical indicators | normalized protein equivalent of total nitrogen appearance(g/kg/d) | the end of the 7-days-study period | 
| biochemical indicators | pre-Alb(mg/dL) | baseline | 
| biochemical indicators | pre-Alb(mg/dL) | one week after the washout period | 
| biochemical indicators | pre-Alb(mg/dL) | the end of the 7-days-study period | 
| biochemical indicators | ferritin(ng/mL) | baseline | 
| biochemical indicators | ferritin(ng/mL) | one week after the washout period | 
| biochemical indicators | ferritin(ng/mL) | the end of the 7-days-study period | 
| biochemical indicators | red blood cell (10^6/μL), white blood count(10^3/μL) | baseline | 
| biochemical indicators | red blood cell (10^6/μL), white blood count(10^3/μL) | one week after the washout period | 
| biochemical indicators | red blood cell (10^6/μL), white blood count(10^3/μL) | the end of the 7-days-study period | 
| biochemical indicators | Hb (g/dL) | baseline | 
| biochemical indicators | Hb (g/dL) | one week after the washout period | 
| biochemical indicators | Hb (g/dL) | the end of the 7-days-study period | 
| biochemical indicators | Hct (%) | baseline | 
| biochemical indicators | Hct (%) | one week after the washout period | 
| biochemical indicators | Hct (%) | the end of the 7-days-study period | 
| biochemical indicators | FGF23 | baseline | 
| biochemical indicators | FGF23 | one week after the washout period | 
| biochemical indicators | FGF23 | the end of the 7-days-study period | 
| biochemical indicators | iPTH (pg/mL) | baseline | 
| biochemical indicators | iPTH (pg/mL) | one week after the washout period | 
| biochemical indicators | iPTH (pg/mL) | the end of the 7-days-study period | 
| biochemical indicators | blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL) | baseline | 
| biochemical indicators | blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL) | one week after the washout period | 
| biochemical indicators | blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL) | the end of the 7-days-study period | 
| biochemical indicators | estimated glomerular filtration rate (ml/min/1.73m^2) | baseline | 
| biochemical indicators | estimated glomerular filtration rate (ml/min/1.73m^2) | one week after the washout period | 
| biochemical indicators | estimated glomerular filtration rate (ml/min/1.73m^2) | the end of the 7-days-study period | 
| inflammation indicators | C reactive protein (mg/dL) | baseline | 
| inflammation indicators | C reactive protein (mg/dL) | one week after the washout period | 
| inflammation indicators | C reactive protein (mg/dL) | the end of the 7-days-study period | 
| inflammation indicators | interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL) | baseline | 
| inflammation indicators | interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL) | one week after the washout period | 
| inflammation indicators | interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL) | the end of the 7-days-study period | 
| Electrolyte | P(mg/dL), Ca(mg/dL), Mg(mg/dL) | baseline | 
| Electrolyte | P(mg/dL), Ca(mg/dL), Mg(mg/dL) | one week after the washout period | 
| Electrolyte | P(mg/dL), Ca(mg/dL), Mg(mg/dL) | the end of the 7-days-study period | 
| Electrolyte | K(mEq/L), Na(mEq/L) | baseline | 
| Electrolyte | K(mEq/L), Na(mEq/L) | one week after the washout period | 
| Electrolyte | K(mEq/L), Na(mEq/L) | the end of the 7-days-study period |