Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SEO186
Study information
Scientific title
Acronym
Study hypothesis
Can nutritional state of CAPD patients be improved by altering diet to achieve recommended energy intake?
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Urological and genital diseases: Renal disease
Intervention
1. Dietary intervention from Research Dietician
2. Conventional dietary advice
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Energy intake expressed as calories/kg body weight
2. Serum albumin, Leptin and IGF
3. Anthropometry - weight, skin fold thickness % body fat
4. Subjective Global Assessment Score
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2001
Overall trial end date
20/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Patients from the CAPD population treated by the Wessex renal unit.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Added December 2008: 59
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2001
Recruitment end date
20/06/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Renal Unit Dietician
Portsmouth
PO3 6AD
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East (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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17720102
Publication citations
-
Results
Sutton D, Higgins B, Stevens JM, Continuous ambulatory peritoneal dialysis patients are unable to increase dietary intake to recommended levels., J Ren Nutr, 2007, 17, 5, 329-335, doi: 10.1053/j.jrn.2007.02.003.