The Effect of Systemic Dietary Instruction on Management... | NCT01329497

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

NCT01329497

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Apr 18, 2011Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Hyperphosphatemia

Interventions

systemic dietary instruction

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jun 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Apr 4, 2011

First Submission Date that Met QC Criteria

Apr 5, 2011

First Posted Date

Apr 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2011

Last Update Posted Date

Apr 18, 2011Estimated

Name	Class
Baxter Healthcare Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
interventional group	Experimental		Other: systemic dietary instruction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
systemic dietary instruction	Other	systemic dietary instruction based on continuous quality improvement (CQI) team-oriented approach	interventional group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma phosphorus levels		up to 1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable on PD for at least three month
Aged from 18 to 75 years old
Informed consent approval

Exclusion Criteria:

Malnutrition (based on SGA results)
Infection or inflammation within 1 month
Concurrent wasting disease (i.e. cancer, tuberculosis)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Na Jiang, MD	Contact	+86-21-53882014		jiangjiang198311@163.com

Overall Officials

Name	Affiliation	Role
Jiaqi Qian, MD	RenJi Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine	Recruiting	Shanghai	Shanghai Municipality	200001	China

Condition Browse Module

MeSH Terms

ID	Term
D054559	Hyperphosphatemia

Ancestor Terms

ID	Term
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided