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Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University of Southampton.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital Southampton NHS Foundation Trust.
Information provided by:
University of Southampton
ClinicalTrials.gov Identifier:
NCT00538200
First received: September 4, 2007
Last updated: January 2, 2009
Last verified: January 2009
History of Changes

September 4, 2007
January 2, 2009
January 2008
September 2010   (final data collection date for primary outcome measure)
The primary outcome measure is Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary outcome measure is Quality of Life [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00538200 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Malnutrition
  • 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.
  • Other: Dietary Advice
    Standard dietary advice
  • 1
    Dietary Advice
    Intervention: Other: Dietary Advice
  • 2
    Supplements
    Intervention: Dietary Supplement: Oral Nutritional Supplements (Fortisip)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact: Marinos Elia, Professor 02380 796317 elia@soton.ac.uk
United Kingdom
 
NCT00538200
ELIA002
No
Christine McGrath Head of Research and Development, Southampton University Hospitals NHS trust
University of Southampton
University Hospital Southampton NHS Foundation Trust.
Principal Investigator: Marinos Elia, Professor University of Southampton
University of Southampton
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP