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Completed

NCT Number: NCT00755768

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

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.

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCL Center for Nephrology

London, NW3 2QG, United Kingdom

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

additional review by dietician

Behavioral

Primary outcomes

  1. phosphate control

  2. calcium phosphate product

Secondary outcomes

  1. parathyroid hormone

  2. number and type of phosphate binders prescribed

Sponsors and collaborators

Lead sponsor

Royal Free Hampstead NHS Trust

Other

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2006
First posted
Sep 19, 2008
Registry last updated
Sep 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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