Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial
A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Outcomes in Patients With COPD
1 other identifier
interventional
85
1 country
1
Brief Summary
The purpose of this study is to determine the best form of dietary intervention to undernourished individuals with COPD. The research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2007
CompletedFirst Posted
Study publicly available on registry
October 2, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedDecember 8, 2014
December 1, 2014
3.7 years
September 4, 2007
December 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is Quality of Life
6 months
Study Arms (2)
1
OTHERDietary Advice
2
OTHERSupplements
Interventions
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.
Eligibility Criteria
You may qualify if:
- Male or female
- 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
You may not qualify if:
- 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
- Bronchiectasis
- Those already under the care of a dietitian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southampton University Hospitals NHS Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marinos Elia, Professor
University of Southampton
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2007
First Posted
October 2, 2007
Study Start
January 1, 2008
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
December 8, 2014
Record last verified: 2014-12