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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01329497
Recruitment Status : Unknown
Verified November 2010 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : April 6, 2011
Last Update Posted : April 18, 2011
Baxter Healthcare Corporation
Information provided by:
Shanghai Jiao Tong University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Other: systemic dietary instruction Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: interventional group Other: systemic dietary instruction
systemic dietary instruction based on continuous quality improvement (CQI) team-oriented approach

Primary Outcome Measures :
  1. Plasma phosphorus levels [ Time Frame: up to 1 year ]

Secondary Outcome Measures :
  1. Plasma calcium levels [ Time Frame: up to one year ]
  2. Carotid artery intima-media thicknesses [ Time Frame: up to 1 year ]
  3. Plasma albumin levels [ Time Frame: up to 1 year ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01329497

Contact: Na Jiang, MD +86-21-53882014

China, Shanghai
Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200001
Contact: Huili Dai, MD    +86-21-58752345 ext 3899   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Baxter Healthcare Corporation
Study Director: Jiaqi Qian, MD RenJi Hospital

Responsible Party: Huili Dai, Shanghai Jiaotong University School of Medicine Identifier: NCT01329497     History of Changes
Other Study ID Numbers: phosphorus
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: April 18, 2011
Last Verified: November 2010

Additional relevant MeSH terms:
Phosphorus Metabolism Disorders
Metabolic Diseases