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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014