NCT00755768CompletedNot Applicable
More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time on Phosphate Levels in End Stage Renal Failure Patients
Royal Free Hampstead NHS Trust2 sites in 1 country75 target enrollmentStarted: January 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- phosphate control
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
phosphate control
calcium phosphate product
Secondary Outcomes
- number and type of phosphate binders prescribed
- parathyroid hormone
Investigators
Study Sites (2)
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