Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial
NCT ID: NCT00538200
Last Updated: 2014-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
85 participants
INTERVENTIONAL
2008-01-31
2011-09-30
Brief Summary
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The research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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1
Dietary Advice
Dietary Advice
Standard dietary advice
2
Supplements
Oral Nutritional Supplements (Fortisip)
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 3 month period.
Interventions
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Oral Nutritional Supplements (Fortisip)
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 3 month period.
Dietary Advice
Standard dietary advice
Eligibility Criteria
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Inclusion Criteria
* Age \>18 years
* At risk of malnutrition
* Competent to provide written informed consent and able to answer questions
* Able to eat and drink
* Willingness to take part in the trial and to follow the trial protocol
* FEV1 \<80% predicted and FEV1/FVC \<0.7
Exclusion Criteria
* Galactosemia
* Receiving current oral nutritional supplementation
* Palliative care
* Chronic renal disease requiring dialysis
* Liver failure
* Malignancy
* Participation in other studies
* Bronchiectasis
* Those already under the care of a dietitian
50 Years
ALL
No
Sponsors
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University Hospital Southampton NHS Foundation Trust
OTHER
University of Southampton
OTHER
Responsible Party
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Principal Investigators
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Marinos Elia, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Southampton
Locations
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Southampton University Hospitals NHS Trust
Southampton, Hampshire, United Kingdom
Countries
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Other Identifiers
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ELIA002
Identifier Type: -
Identifier Source: org_study_id