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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01329497
First received: April 4, 2011
Last updated: April 15, 2011
Last verified: November 2010
  Purpose

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 Intervention
Hyperphosphatemia
Other: systemic dietary instruction

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

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Plasma phosphorus levels [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma calcium levels [ Time Frame: up to one year ] [ Designated as safety issue: No ]
  • Carotid artery intima-media thicknesses [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Plasma albumin levels [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: interventional group Other: systemic dietary instruction
systemic dietary instruction based on continuous quality improvement (CQI) team-oriented approach

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329497

Contacts
Contact: Na Jiang, MD +86-21-53882014 jiangjiang198311@163.com

Locations
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    dhl_sh@163.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Baxter Healthcare Corporation
Investigators
Study Director: Jiaqi Qian, MD RenJi Hospital
  More Information

No publications provided

Responsible Party: Huili Dai, Shanghai Jiaotong University School of Medicine
ClinicalTrials.gov Identifier: NCT01329497     History of Changes
Other Study ID Numbers: phosphorus
Study First Received: April 4, 2011
Last Updated: April 15, 2011
Health Authority: China: Shanghai Jiaotong University

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014