Nutrition Counseling to Lower Serum Phosphorus Levels | NCT00296439

Studies
Nutrition Counseling to Lower Serum Phosphorus Levels

NCT00296439

Sponsor

Edward Hines Jr. VA Hospital

Status

Unknown status

Last Update Posted

Feb 27, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Hemodialysis
Nutrition

Interventions

Behavior

Countries

United States

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

Feb 2006

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

Feb 2006

Primary Completion Date

Not provided

Completion Date

Feb 2006

First Submitted Date

Feb 23, 2006

First Submission Date that Met QC Criteria

Feb 23, 2006

First Posted Date

Feb 27, 2006Estimated

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

Feb 23, 2006

Last Update Posted Date

Feb 27, 2006Estimated

Description Module

Brief Summary

Hemodialysis patients who receive frequent weekly nutrition counseling using motivational interviewing techniques will have lower serum phosphorus levels compared to patients receiving standard treatment.

Detailed Description

Hemodialysis patients will receive weekly nutrition counseling on how to lower their serum Phosphorus levels. Motivational interviewing techniques and strategies will be employed such as reflective listening, using affirmations, and summarizing. Average serum Phosphorus levels pre-dialysis will be compared to s.Ph post counseling. This will be compared to a group receiving nutrition counseling via standard treatment on a monthly basis.

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

Name	Type	Description	Arm Group Labels	Other Names
Behavior	Behavioral

Measure	Description	Time Frame
serum Phosphorus levels

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ESRD patients on dialysis with serum Ph > 5.5 mg/dL four of six labs over 6 months, mentally competent

Exclusion Criteria:

ESRD patients on dialysis with serum Ph < 5.5 mg/dL four of six labs over 6 months, mentally incompetent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sharon Foley, MS	Hines VA Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Edward Hines,Jr., VA Hospital	Suspended	Hines	Illinois	60141	United States