Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial
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|ClinicalTrials.gov Identifier: NCT00538200|
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : December 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition||Dietary Supplement: Oral Nutritional Supplements (Fortisip) Other: Dietary Advice||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|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|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
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.
- The primary outcome measure is Quality of Life [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538200
|Southampton University Hospitals NHS Trust|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Principal Investigator:||Marinos Elia, Professor||University of Southampton|