Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00538200
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : December 8, 2014
University Hospital Southampton NHS Foundation Trust
Information provided by (Responsible Party):
University of Southampton

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.

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
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
Study Start Date : January 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Dietary Advice
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.

Primary Outcome Measures :
  1. The primary outcome measure is Quality of Life [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00538200

United Kingdom
Southampton University Hospitals NHS Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Sponsors and Collaborators
University of Southampton
University Hospital Southampton NHS Foundation Trust
Principal Investigator: Marinos Elia, Professor University of Southampton

Responsible Party: University of Southampton Identifier: NCT00538200     History of Changes
Other Study ID Numbers: ELIA002
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by University of Southampton:

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Nutrition Disorders