NCT01329497

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 18, 2011

Status Verified

November 1, 2010

Enrollment Period

1.4 years

First QC Date

April 4, 2011

Last Update Submit

April 15, 2011

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

  • Plasma phosphorus levels

    up to 1 year

Secondary Outcomes (3)

  • Plasma calcium levels

    up to one year

  • Carotid artery intima-media thicknesses

    up to 1 year

  • Plasma albumin levels

    up to 1 year

Study Arms (1)

interventional group

EXPERIMENTAL
Other: systemic dietary instruction

Interventions

systemic dietary instructionOTHER

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

interventional group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

MeSH Terms

Conditions

Hyperphosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jiaqi Qian, MD

    RenJi Hospital

    STUDY DIRECTOR

Central Study Contacts

Na Jiang, MD

CONTACT

+86-21-53882014jiangjiang198311@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 6, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

April 18, 2011

Record last verified: 2010-11

Locations

CN(1)