Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
29/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Dawn Yokum

ORCID ID

Contact details

Department of Nutrition & Dietetics
59 Philpot Street
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
+44 020 7377 7735
dawn.yokum@bartsandthelondon.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0205118456

Study information

Scientific title

Acronym

Study hypothesis

To achieve good serum phosphate control in haemodialysis patients compliance with a phosphate restricted diet and phosphate binder medication is important. The aim of this project is to evaluate the effectiveness of different education methods including group teaching sessions and intensive phosphate clinics. We hope to find the best methods of educating people to achieve the desired levels.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Urological and Genital Diseases: Haemodialysis

Intervention

68 patients will be recruited and randomised into 4 groups. Baseline data on their phosphate knowledge and routine blood chemistry will be obtained. Two groups will attend group education sessions run by the renal dietician and the renal pharmacist. The other two groups will act as controls. At the end of this phase the phosphate questionnaire will be repeated and blood will be taken for analysis. The patients will then complete a 1 month wash-out phase. At the end of this they will repeat the questionnaire and have blood taken. Two groups will attend monthly intensive phosphate clinics for a 4 month period. The other two groups will act as controls. The questionnaire and blood test will be repeated at the end of this phase which is also the end of the study.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Group 1 (both interventions): results for phosphate knowledge and serum phosphate control should be the best out of all the groups
Groups 2 + 3 (each had one intervention only, group teaching session and intensive clinic respectively): results for phosphate knowledge and serum phosphate control should improve versus baseline
Group 4 (control): results for phosphate knowledge and serum phosphate control should be similar to baseline

Secondary outcome measures

Not provided at time of registration

Overall trial start date

04/11/2002

Overall trial end date

04/11/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients will be recruited from Barts and The London NHS Trust haemodialysis population. This includes hospital and satellite units. Inclusion criteria:
1. Serum phosphate: >1.7 mmol/l
2. Serum calcium: 2.2 - 2.6 mmol/l
3. Serum parathyroid hormone (PTH): 10-50 pmol.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

68

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

04/11/2002

Recruitment end date

04/11/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Nutrition & Dietetics
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Barts and The London NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18940656

Publication citations

  1. Results

    Yokum D, Glass G, Cheung CF, Cunningham J, Fan S, Madden AM, Evaluation of a phosphate management protocol to achieve optimum serum phosphate levels in hemodialysis patients., J Ren Nutr, 2008, 18, 6, 521-529, doi: 10.1053/j.jrn.2008.05.003.

Additional files

Editorial Notes