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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.
ClinicalTrials.gov Identifier: NCT00538200
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : December 8, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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
Malnutrition Dietary Supplement: Oral Nutritional Supplements (Fortisip) Other: Dietary Advice

Study Design

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
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
1
Dietary Advice
Other: Dietary Advice
Standard dietary advice
2
Supplements
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.


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00538200


Locations
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
Investigators
Principal Investigator: Marinos Elia, Professor University of Southampton
More Information

Responsible Party: University of Southampton
ClinicalTrials.gov 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:
Nutrition
COPD

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