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

Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755768
• Other study ID #: 05/Q0504/46
• Secondary ID: BRS grantR&D 711
• Status: Completed
• Phase: N/A
• First received: September 17, 2008
• Last updated: September 18, 2008
• Start date: January 2006
• Est. completion date: September 2006

Study information

• Verified date: September 2008
• Source: Royal Free Hampstead NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Other known NCT identifiers

• NCT00454727

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Behavioral:
• additional review by dietician

Locations

Country	Name	City	State
United Kingdom	UCL Center for Nephrology	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Free Hampstead NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	phosphate control
Primary	calcium phosphate product
Secondary	parathyroid hormone
Secondary	number and type of phosphate binders prescribed