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

NCT ID: NCT01329497

Last Updated: 2011-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperphosphatemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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interventional group

Group Type EXPERIMENTAL

systemic dietary instruction

Intervention Type OTHER

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

Interventions

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systemic dietary instruction

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Shanghai Jiaotong University School of Medicine

Principal Investigators

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Jiaqi Qian, MD

Role: STUDY_DIRECTOR

RenJi Hospital

Locations

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Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Na Jiang, MD

Role: CONTACT

+86-21-53882014

Facility Contacts

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Huili Dai, MD

Role: primary

+86-21-58752345 ext. 3899

Other Identifiers

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phosphorus

Identifier Type: -

Identifier Source: org_study_id

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