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

This study has been completed.

Sponsor:

Information provided by:

Royal Free Hampstead NHS Trust

ClinicalTrials.gov Identifier:

NCT00755768

First received: September 17, 2008

Last updated: September 18, 2008

Last verified: September 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 17, 2008

Last Updated Date

September 18, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

phosphate control
calcium phosphate product

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00755768 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

parathyroid hormone
number and type of phosphate binders prescribed

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time on Phosphate Levels in End Stage Renal Failure Patients

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Renal Failure

Intervention ^ICMJE

Behavioral: additional review by dietician

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00755768

Other Study ID Numbers ^ICMJE

05/Q0504/46, BRS grant, R&D 7119M

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Royal Free Hampstead NHS Trust

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

andrew davenport, md

UCL Center for nephrology

Information Provided By

Royal Free Hampstead NHS Trust

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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