NCT00755768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2008

Completed
Last Updated

September 19, 2008

Status Verified

September 1, 2008

First QC Date

September 17, 2008

Last Update Submit

September 18, 2008

Conditions

Renal Failure

Keywords

hemodialysisphosphatecalcium phosphate productdieticiandietetic advice

Outcome Measures

Primary Outcomes (2)

  • phosphate control

  • calcium phosphate product

Secondary Outcomes (2)

  • parathyroid hormone

  • number and type of phosphate binders prescribed

Interventions

additional review by dieticianBEHAVIORAL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCL Center for Nephrology

London, London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • andrew davenport, md

    UCL Center for nephrology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 19, 2008

Study Start

January 1, 2006

Study Completion

September 1, 2006

Last Updated

September 19, 2008

Record last verified: 2008-09

Locations

GB(1)