NCT00538200CompletedNot Applicable
A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Outcomes in Patients With COPD
University of Southampton1 site in 1 country85 target enrollmentStarted: January 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Southampton
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- The primary outcome measure is Quality of Life
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
- •Bronchiectasis
- •Those already under the care of a dietitian
Arms & Interventions
1
Other
Dietary Advice
Intervention: Dietary Advice (Other)
2
Other
Supplements
Intervention: Oral Nutritional Supplements (Fortisip) (Dietary Supplement)
Outcomes
Primary Outcomes
The primary outcome measure is Quality of Life
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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