NCT04645459

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

December 3, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

December 4, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

October 15, 2020

Last Update Submit

December 3, 2020

Conditions

Hemodialysis Patients

Outcome Measures

Primary Outcomes (63)

  • 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

Study Arms (2)

low phosphorus meal group (LP group)

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

The boiling method did not process for the control meals.

Other: control meals

Interventions

low phosphorus mealsOTHER

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.

low phosphorus meal group (LP group)
control mealsOTHER

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 group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemodialysis patients, ≥ 20 years of age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shuang Ho Hospital

New Taipei City, Taiwan

RECRUITING

Study Officials

  • Mai-Szu Wu

    Taipei Medical University Shuang Ho Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Y.J. Chen

CONTACT

+886963358528d507103001@tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2020

First Posted

November 27, 2020

Study Start

December 3, 2020

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

December 4, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)