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More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Royal Free Hampstead NHS Trust
ClinicalTrials.gov Identifier:
NCT00755768
First received: September 17, 2008
Last updated: September 18, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention
Renal Failure
 Behavioral: additional review by dietician

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Free Hampstead NHS Trust:

Primary Outcome Measures:
  • phosphate control
  • calcium phosphate product

Secondary Outcome Measures:
  • parathyroid hormone
  • number and type of phosphate binders prescribed

Estimated Enrollment: 75
Study Start Date: January 2006
Study Completion Date: September 2006
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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755768

Locations
United Kingdom
UCL Center for Nephrology
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Royal Free Hampstead NHS Trust
Investigators
Principal Investigator: andrew davenport, md UCL Center for nephrology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00755768     History of Changes
Obsolete Identifiers: NCT00454727
Other Study ID Numbers: 05/Q0504/46, BRS grant, R&D 7119M
Study First Received: September 17, 2008
Last Updated: September 18, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Free Hampstead NHS Trust:
hemodialysis
phosphate
calcium phosphate product
dietician
dietetic advice

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013