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

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.

Study Overview

• Status: Unknown
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Other: systemic dietary instruction

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200001
      • Recruiting
      • Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Huili Dai, MD; Phone Number: 3899 +86-21-58752345; Email: dhl_sh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma phosphorus levels	up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma calcium levels	up to one year
Carotid artery intima-media thicknesses	up to 1 year
Plasma albumin levels	up to 1 year

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Baxter Healthcare Corporation
• Investigators: Study Director: Jiaqi Qian, MD, Renji Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (Estimate): April 6, 2011

Study Record Updates

• Last Update Posted (Estimate): April 18, 2011
• Last Update Submitted That Met QC Criteria: April 15, 2011
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: phosphorus