Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial
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.
|Malnutrition||Dietary Supplement: Oral Nutritional Supplements (Fortisip) Other: Dietary Advice|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|Official Title:||A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Outcomes in Patients With COPD|
- The primary outcome measure is Quality of Life [ Time Frame: 6 months ]
|Study Start Date:||January 2008|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Other: Dietary Advice
Standard dietary advice
Dietary Supplement: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538200
|Southampton University Hospitals NHS Trust|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Principal Investigator:||Marinos Elia, Professor||University of Southampton|