Renal FailureNCT00755768
More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time in Dialysis Patients
A study testing additional review by dietician in people with Renal Failure, run by Royal Free Hampstead NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- additional review by dietician
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2006to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Renal Failure
- Being tested
- additional review by dietician
- Keywords
- hemodialysis, phosphate, calcium phosphate product, dietician, dietetic advice
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional review by dieticianBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
phosphate control
calcium phosphate product
Secondary outcomes (2)
parathyroid hormone
number and type of phosphate binders prescribed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startJan 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Royal Free Hampstead NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- andrew davenport, md, Principal investigator, UCL Center for nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755768
- Sponsor's protocol ID
- 05/Q0504/46
- Other IDs
- BRS grant, R&D 7119M
- Status last verified
- Sep 2008
- First submitted
- 17 Sep 2008
- Last updated
- 19 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00755768
- Acronym / sponsor ID
- 05/Q0504/46
- Conditions
- Renal Failure
- Keywords
- hemodialysis, phosphate, calcium phosphate product, dietician, dietetic advice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Royal Free Hampstead NHS TrustUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Sep 2006 (actual)
- First posted
- 19 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- pregnancy
- unable to give consent
- phosphate < 1.8 mmol/l
- inadequate dialysis
- aged < 18 or > 80
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| additional review by dietician | Behavioural | – |
Primary outcome
phosphate control
calcium phosphate product
2 secondary outcomes
parathyroid hormone
number and type of phosphate binders prescribed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
andrew davenport, md principal investigator
UCL Center for nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional review by dietician in people with Renal Failure, run by Royal Free Hampstead NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phosphate control. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2008.