The Influence of Low Phosphorus in Hemodialysis Patients

Hemodialysis Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645459
• Other study ID #: N202004062
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: May 2020
• Source: Taipei Medical University
• Contact: Barbara Y.J. Chen
• Phone: +886963358528
• Email: d507103001[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Hemodialysis patients, = 20 years of age

Exclusion Criteria:

• = 80 years of age, liver cirrhosis, cancer, pregnancy, vegetarian

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Other:
• low phosphorus meals
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.
• control meals
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.

Locations

Country	Name	City	State
Taiwan	Shuang Ho Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

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