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

NCT ID: NCT00755768

Last Updated: 2008-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-09-30

Brief Summary

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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

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* 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

Conditions

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Renal Failure

Keywords

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hemodialysis phosphate calcium phosphate product dietician dietetic advice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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additional review by dietician

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Free Hampstead NHS Trust

OTHER

Sponsor Role lead

Principal Investigators

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andrew davenport, md

Role: PRINCIPAL_INVESTIGATOR

UCL Center for nephrology

Locations

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UCL Center for Nephrology

London, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BRS grant

Identifier Type: -

Identifier Source: secondary_id

R&D 7119M

Identifier Type: -

Identifier Source: secondary_id

05/Q0504/46

Identifier Type: -

Identifier Source: org_study_id

NCT00454727

Identifier Type: -

Identifier Source: nct_alias