- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00515125
Community Oral Nutrition Support Trial
A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hampshire
-
Southampton, Hampshire, United Kingdom
- Care Homes in Hampshire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Dietary Advice
|
Dietary Advice sheet
|
Other: Oral Nutritional Supplements
|
These products are classified as non-medicinal, borderline substances, foods for special medical purposes. A range of commercially available liquid oral nutritional supplements (Fortisip) will be offered daily for a 12 week period. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome measure is Quality of Life
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marinos Elia, Professor, University of Southampton
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ELIA0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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