Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial

This study has been completed.
Sponsor:
Collaborator:
University Hospital Southampton NHS Foundation Trust.
Information provided by (Responsible Party):
University of Southampton
ClinicalTrials.gov Identifier:
NCT00538200
First received: September 4, 2007
Last updated: December 5, 2014
Last verified: December 2014
  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:


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 ]

Enrollment: 85
Study Start Date: January 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Southampton
ClinicalTrials.gov Identifier: NCT00538200     History of Changes
Other Study ID Numbers: ELIA002
Study First Received: September 4, 2007
Last Updated: December 5, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Southampton:
Nutrition
COPD

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

ClinicalTrials.gov processed this record on September 03, 2015