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More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time in Dialysis Patients

Primary Purpose

Renal Failure

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
additional review by dietician
Sponsored by
Royal Free Hampstead NHS Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Renal Failure focused on measuring hemodialysis, phosphate, calcium phosphate product, dietician, dietetic advice

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stable chronic hemodialysis patients
  • serum phosphate > 1.8 mmol/l sustained over 3 months prior to trial entry adequate dialysis treatment as assessed by urea reduction

Exclusion Criteria:

  • pregnancy
  • unable to give consent
  • phosphate < 1.8 mmol/l
  • inadequate dialysis
  • aged < 18 or > 80
  • poor nutritional state
  • weight loss in proceeding three months

Sites / Locations

  • UCL Center for Nephrology

Outcomes

Primary Outcome Measures

phosphate control
calcium phosphate product

Secondary Outcome Measures

parathyroid hormone
number and type of phosphate binders prescribed

Full Information

First Posted
September 17, 2008
Last Updated
September 18, 2008
Sponsor
Royal Free Hampstead NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00755768
Brief Title
More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time in Dialysis Patients
Official Title
More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time on Phosphate Levels in End Stage Renal Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Free Hampstead NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether spending more time with a dietitian will improve dietary compliance in a group of hemodialysis patients, with particular respect to phosphate control.
Detailed Description
randomised prospective controlled trial stable haemodialysis patients on thrice weekly haemodialysis (URR > 66%) either had standard dietetic review - 6 monthly or intensive review - monthly all patients had to have a serum phosphate > 1.8 mmol/l over the previous three months to be recruited study period 6 months, and then patients followed for a further 3 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
hemodialysis, phosphate, calcium phosphate product, dietician, dietetic advice

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
additional review by dietician
Primary Outcome Measure Information:
Title
phosphate control
Title
calcium phosphate product
Secondary Outcome Measure Information:
Title
parathyroid hormone
Title
number and type of phosphate binders prescribed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stable chronic hemodialysis patients serum phosphate > 1.8 mmol/l sustained over 3 months prior to trial entry adequate dialysis treatment as assessed by urea reduction Exclusion Criteria: pregnancy unable to give consent phosphate < 1.8 mmol/l inadequate dialysis aged < 18 or > 80 poor nutritional state weight loss in proceeding three months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
andrew davenport, md
Organizational Affiliation
UCL Center for nephrology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCL Center for Nephrology
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time in Dialysis Patients

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