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NCT01329497 Clinical Trial

The Effect of Systemic Dietary Instruction on Management of Plasma Phosphorus Levels in Peritoneal Dialysis (PD) Patients

Hyperphosphatemia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01329497
Other study ID # phosphorus
Secondary ID
Status Recruiting
Phase N/A
First received April 4, 2011
Last updated April 15, 2011
Start date January 2011
Est. completion date December 2012

Study information
Verified date November 2010
Source Shanghai Jiao Tong University School of Medicine
Contact Na Jiang, MD
Phone +86-21-53882014
Email jiangjiang198311@163.com
Is FDA regulated No
Health authority China: Shanghai Jiaotong University
Study type Interventional

Clinical Trial Summary

Hyperphosphatemia is highly prevalent in PD patients, and it is an independent risk factor for all-cause and cardiovascular mortality in these patients. Effective treatments are limited in suppressing plasma phosphorous. Because of the nearly linear relationship between protein and phosphorus intake, high dietary protein intake (DPI, 1.2-1.3g/kg/d recommended by KDOQI) would load high phosphorus burden in PD patients. It is suggested that hyperphosphatemia is hard to avoid under such a DPI level, even as the patients take sufficient phosphorus blinders and receive high PD dosage. The present study is to investigate whether systemic dietary instruction would show effects on control of hyperphosphatemia in PD patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Stable on PD for at least three month

2. Aged from 18 to 75 years old

3. Informed consent approval

Exclusion Criteria:

1. Malnutrition (based on SGA results)

2. Infection or inflammation within 1 month

3. Concurrent wasting disease (i.e. cancer, tuberculosis)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• systemic dietary instruction
systemic dietary instruction based on continuous quality improvement (CQI) team-oriented approach

Locations
Country Name City State
China Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai

Sponsors (2)
Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine Baxter Healthcare Corporation

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma phosphorus levels up to 1 year No
Secondary Plasma calcium levels up to one year No
Secondary Carotid artery intima-media thicknesses up to 1 year No
Secondary Plasma albumin levels up to 1 year Yes
See also
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Completed NCT01003223 - Phosphate Kinetic Modeling N/A
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Completed NCT00508885 - The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients Phase 1/Phase 2
Completed NCT04551300 - A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients Phase 2
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Completed NCT00542815 - A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia Phase 3
Completed NCT04549597 - Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia Phase 4