More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time in Dialysis Patients
September 18, 2008 updated by: Royal Free Hampstead NHS Trust
More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time on Phosphate Levels in End Stage Renal Failure Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, NW3 2QG
- UCL Center for Nephrology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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phosphate control
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calcium phosphate product
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Secondary Outcome Measures
Outcome Measure |
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parathyroid hormone
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number and type of phosphate binders prescribed
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: andrew davenport, md, UCL Center for Nephrology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
September 17, 2008
First Submitted That Met QC Criteria
September 18, 2008
First Posted (Estimate)
September 19, 2008
Study Record Updates
Last Update Posted (Estimate)
September 19, 2008
Last Update Submitted That Met QC Criteria
September 18, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/Q0504/46
- BRS grant
- R&D 7119M
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.