ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00755768
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : September 19, 2008
Sponsor:
Information provided by:
Royal Free Hampstead NHS Trust

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.

Condition or disease Intervention/treatment Phase
Renal Failure Behavioral: additional review by dietician Not Applicable

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 Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2006
Actual Study Completion Date : September 2006



Primary Outcome Measures :
  1. phosphate control
  2. calcium phosphate product

Secondary Outcome Measures :
  1. parathyroid hormone
  2. number and type of phosphate binders prescribed


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00755768     History of Changes
Obsolete Identifiers: NCT00454727
Other Study ID Numbers: 05/Q0504/46
BRS grant
R&D 7119M
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008

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