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

Sponsor

Royal Free Hampstead NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00755768

Collaborator

(none)

Enrollment

Location

Duration (Months)

9.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Failure	Behavioral: additional review by dietician	N/A

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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 Start Date :

Jan 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

phosphate control []
calcium phosphate product []

Secondary Outcome Measures

parathyroid hormone []
number and type of phosphate binders prescribed []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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