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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