- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04645459
The Influence of Low Phosphorus in Hemodialysis Patients
The Influence of Low Phosphorus Meals on Serum Phosphorus Concentration and Inflammatory Indicators in Hemodialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Barbara Y.J. Chen
- Phone Number: +886963358528
- Email: d507103001@tmu.edu.tw
Study Locations
-
-
-
New Taipei City, Taiwan
- Recruiting
- Shuang Ho Hospital
-
Contact:
- Mai-Szu Wu
- Phone Number: +886(2)28837300
- Email: maiszuwu@tmu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hemodialysis patients, ≥ 20 years of age
Exclusion Criteria:
- ≥ 80 years of age, liver cirrhosis, cancer, pregnancy, vegetarian
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: low phosphorus meal group (LP group)
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.
|
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.
|
Placebo Comparator: control group
The boiling method did not process for the 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
anthropometric measurement
Time Frame: baseline
|
body height (cm)
|
baseline
|
anthropometric measurement
Time Frame: one week after the washout period
|
body height (cm)
|
one week after the washout period
|
anthropometric measurement
Time Frame: the end of the 7-days-study period
|
body height (cm)
|
the end of the 7-days-study period
|
anthropometric measurement
Time Frame: baseline
|
body weight before hemodialysis (Kg), dry weight (Kg)
|
baseline
|
anthropometric measurement
Time Frame: one week after the washout period
|
body weight before hemodialysis (Kg), dry weight (Kg)
|
one week after the washout period
|
anthropometric measurement
Time Frame: the end of the 7-days-study period
|
body weight before hemodialysis (Kg), dry weight (Kg)
|
the end of the 7-days-study period
|
blood pressure
Time Frame: baseline
|
systolic blood pressure (mmHg), diastolic blood pressure (mmHg)
|
baseline
|
blood pressure
Time Frame: one week after the washout period
|
systolic blood pressure (mmHg), diastolic blood pressure (mmHg)
|
one week after the washout period
|
blood pressure
Time Frame: the end of the 7-days-study period
|
systolic blood pressure (mmHg), diastolic blood pressure (mmHg)
|
the end of the 7-days-study period
|
dietary contents
Time Frame: baseline
|
24-hour dietary recall
|
baseline
|
dietary contents
Time Frame: one week after the washout period
|
24-hour dietary recall
|
one week after the washout period
|
dietary contents
Time Frame: the end of the 7-days-study period
|
24-hour dietary recall
|
the end of the 7-days-study period
|
phosphate binder administration
Time Frame: baseline
|
type and dosing frequency
|
baseline
|
phosphate binder administration
Time Frame: one week after the washout period
|
type and dosing frequency
|
one week after the washout period
|
phosphate binder administration
Time Frame: the end of the 7-days-study period
|
type and dosing frequency
|
the end of the 7-days-study period
|
indicators of dialysis adequacy
Time Frame: baseline
|
Kt/V
|
baseline
|
indicators of dialysis adequacy
Time Frame: one week after the washout period
|
Kt/V
|
one week after the washout period
|
indicators of dialysis adequacy
Time Frame: the end of the 7-days-study period
|
Kt/V
|
the end of the 7-days-study period
|
blood lipid indicators
Time Frame: baseline
|
LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)
|
baseline
|
blood lipid indicators
Time Frame: one week after the washout period
|
LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)
|
one week after the washout period
|
blood lipid indicators
Time Frame: the end of the 7-days-study period
|
LDL(mg/dL), HDL (mg/dL) , cholesterol (mg/dL) , triglyceride (mg/dL)
|
the end of the 7-days-study period
|
biochemical indicators
Time Frame: baseline
|
normalized protein equivalent of total nitrogen appearance(g/kg/d)
|
baseline
|
biochemical indicators
Time Frame: one week after the washout period
|
normalized protein equivalent of total nitrogen appearance(g/kg/d)
|
one week after the washout period
|
biochemical indicators
Time Frame: the end of the 7-days-study period
|
normalized protein equivalent of total nitrogen appearance(g/kg/d)
|
the end of the 7-days-study period
|
biochemical indicators
Time Frame: baseline
|
pre-Alb(mg/dL)
|
baseline
|
biochemical indicators
Time Frame: one week after the washout period
|
pre-Alb(mg/dL)
|
one week after the washout period
|
biochemical indicators
Time Frame: the end of the 7-days-study period
|
pre-Alb(mg/dL)
|
the end of the 7-days-study period
|
biochemical indicators
Time Frame: baseline
|
ferritin(ng/mL)
|
baseline
|
biochemical indicators
Time Frame: one week after the washout period
|
ferritin(ng/mL)
|
one week after the washout period
|
biochemical indicators
Time Frame: the end of the 7-days-study period
|
ferritin(ng/mL)
|
the end of the 7-days-study period
|
biochemical indicators
Time Frame: baseline
|
red blood cell (10^6/μL), white blood count(10^3/μL)
|
baseline
|
biochemical indicators
Time Frame: one week after the washout period
|
red blood cell (10^6/μL), white blood count(10^3/μL)
|
one week after the washout period
|
biochemical indicators
Time Frame: the end of the 7-days-study period
|
red blood cell (10^6/μL), white blood count(10^3/μL)
|
the end of the 7-days-study period
|
biochemical indicators
Time Frame: baseline
|
Hb (g/dL)
|
baseline
|
biochemical indicators
Time Frame: one week after the washout period
|
Hb (g/dL)
|
one week after the washout period
|
biochemical indicators
Time Frame: the end of the 7-days-study period
|
Hb (g/dL)
|
the end of the 7-days-study period
|
biochemical indicators
Time Frame: baseline
|
Hct (%)
|
baseline
|
biochemical indicators
Time Frame: one week after the washout period
|
Hct (%)
|
one week after the washout period
|
biochemical indicators
Time Frame: the end of the 7-days-study period
|
Hct (%)
|
the end of the 7-days-study period
|
biochemical indicators
Time Frame: baseline
|
FGF23
|
baseline
|
biochemical indicators
Time Frame: one week after the washout period
|
FGF23
|
one week after the washout period
|
biochemical indicators
Time Frame: the end of the 7-days-study period
|
FGF23
|
the end of the 7-days-study period
|
biochemical indicators
Time Frame: baseline
|
iPTH (pg/mL)
|
baseline
|
biochemical indicators
Time Frame: one week after the washout period
|
iPTH (pg/mL)
|
one week after the washout period
|
biochemical indicators
Time Frame: the end of the 7-days-study period
|
iPTH (pg/mL)
|
the end of the 7-days-study period
|
biochemical indicators
Time Frame: baseline
|
blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL)
|
baseline
|
biochemical indicators
Time Frame: one week after the washout period
|
blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL)
|
one week after the washout period
|
biochemical indicators
Time Frame: the end of the 7-days-study period
|
blood urea nitrogen(mg/dL) , creatinine(mg/dL) , uric acid(mg/dL)
|
the end of the 7-days-study period
|
biochemical indicators
Time Frame: baseline
|
estimated glomerular filtration rate (ml/min/1.73m^2)
|
baseline
|
biochemical indicators
Time Frame: one week after the washout period
|
estimated glomerular filtration rate (ml/min/1.73m^2)
|
one week after the washout period
|
biochemical indicators
Time Frame: the end of the 7-days-study period
|
estimated glomerular filtration rate (ml/min/1.73m^2)
|
the end of the 7-days-study period
|
inflammation indicators
Time Frame: baseline
|
C reactive protein (mg/dL)
|
baseline
|
inflammation indicators
Time Frame: one week after the washout period
|
C reactive protein (mg/dL)
|
one week after the washout period
|
inflammation indicators
Time Frame: the end of the 7-days-study period
|
C reactive protein (mg/dL)
|
the end of the 7-days-study period
|
inflammation indicators
Time Frame: baseline
|
interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL)
|
baseline
|
inflammation indicators
Time Frame: one week after the washout period
|
interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL)
|
one week after the washout period
|
inflammation indicators
Time Frame: the end of the 7-days-study period
|
interleukin-1 (pg/mL) , interleukin-6 (pg/mL) , tumor necrosis factor-α (pg/mL)
|
the end of the 7-days-study period
|
Electrolyte
Time Frame: baseline
|
P(mg/dL), Ca(mg/dL), Mg(mg/dL)
|
baseline
|
Electrolyte
Time Frame: one week after the washout period
|
P(mg/dL), Ca(mg/dL), Mg(mg/dL)
|
one week after the washout period
|
Electrolyte
Time Frame: the end of the 7-days-study period
|
P(mg/dL), Ca(mg/dL), Mg(mg/dL)
|
the end of the 7-days-study period
|
Electrolyte
Time Frame: baseline
|
K(mEq/L), Na(mEq/L)
|
baseline
|
Electrolyte
Time Frame: one week after the washout period
|
K(mEq/L), Na(mEq/L)
|
one week after the washout period
|
Electrolyte
Time Frame: the end of the 7-days-study period
|
K(mEq/L), Na(mEq/L)
|
the end of the 7-days-study period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mai-Szu Wu, Taipei Medical University Shuang Ho Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- N202004062
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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