Community Nutrition Support Trial | Recruiting
Community Nutrition Support Trial

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Malnutrition
Marinos Elia, Professor
02380 796317
See all trial contact details
Primary Contact Details
Recruiting
Recruitment Status
NCT00515125
Primary Trial ID Number
Summary
The purpose of this study is to determine the best form of dietary intervention to undernourished elderly individuals in care homes. The research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice as the first line treatment for malnutrition.
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Study Type
Interventional
Intervention
Behavioral : Dietary Advice, Dietary Supplement : Oral Nutritional Supplements (Fortisip)

Study Arm Groups : 1, 2

Intervention Type
See Interventions above
Primary Outcome Measures
  • The primary outcome measure is Quality of Life; 6 months
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
50 Years - N/A
Who Can Participate
Patients
Number of Participants
300
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Male or female
  • - Age > 50 years
  • - At risk of malnutrition
  • - Competent to provide written informed consent and to answer questions
  • - Able to eat and drink
  • - Willingness to take part in the trial and to follow the trial protocol
  • Exclusion Criteria:
  • - Requirement for tube or parenteral nutrition
  • - Galactosemia
  • - Receiving current oral nutritional supplementation
  • - Palliative care
  • - Chronic renal disease requiring dialysis
  • - Liver failure
  • - Malignancy
  • - Participation in other studies
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Southampton General Hospital
Southampton
Trial Contact(s)
Primary Trial Contact
Marinos Elia, Professor
elia@soton.ac.uk
02380 796317
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Sorry, this information is not available
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
ELIA0001
Sponsor(s)
University of Southampton
Key Dates

Recruitment Start Date

Aug 2007

Recruitment End Date

Aug 2010

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

10 Aug 2007

Last Updated

02 Jan 2009