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Clinical Trials/NCT00538200
NCT00538200
Completed
N/A

A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Outcomes in Patients With COPD

University of Southampton1 site in 1 country85 target enrollmentJanuary 2008
ConditionsMalnutrition

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malnutrition
Sponsor
University of Southampton
Enrollment
85
Locations
1
Primary Endpoint
The primary outcome measure is Quality of Life
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
September 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

The primary outcome measure is Quality of Life

Time Frame: 6 months

Study Sites (1)

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