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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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Outcomes in Patients With COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Southampton:

Primary Outcome Measures:
  • The primary outcome measure is Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538200

Contacts
Contact: Marinos Elia, Professor 02380 796317 elia@soton.ac.uk

Locations
United Kingdom
Southampton University Hospitals NHS Trust Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Professor M Elia     02380 796317     elia@soton.ac.uk    
Sponsors and Collaborators
University of Southampton
University Hospital Southampton NHS Foundation Trust.
Investigators
Principal Investigator: Marinos Elia, Professor University of Southampton
  More Information

No publications provided

Responsible Party: Christine McGrath Head of Research and Development, Southampton University Hospitals NHS trust
ClinicalTrials.gov Identifier: NCT00538200     History of Changes
Other Study ID Numbers: ELIA002
Study First Received: September 4, 2007
Last Updated: January 2, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Southampton:
Nutrition
COPD

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

ClinicalTrials.gov processed this record on May 21, 2013