More Time Better Outcome – a Randomised Trial to Investigate the Effect of More Dietetic Time in Dialysis Patients
Overview
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.
Full Title of Study: “More Time Better Outcome – a Randomised Trial to Investigate the Effect of More Dietetic Time on Phosphate Levels in End Stage Renal Failure Patients”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Health Services Research
- Masking: None (Open Label)
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
Interventions
- Behavioral: additional review by dietician
Clinical Trial Outcome Measures
Primary Measures
- phosphate control
- calcium phosphate product
Secondary Measures
- parathyroid hormone
- number and type of phosphate binders prescribed
Participating in This Clinical Trial
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 Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Royal Free Hampstead NHS Trust
- Overall Official(s)
- andrew davenport, md, Principal Investigator, UCL Center for nephrology
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