Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial

December 5, 2014 updated by: University of Southampton

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Dietary Advice
Other: Dietary Advice
Standard dietary advice
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is Quality of Life
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southampton

Collaborators

University Hospital Southampton NHS Foundation Trust

Investigators

  • Principal Investigator: Marinos Elia, Professor, University of Southampton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

October 1, 2007

First Posted (Estimate)

October 2, 2007

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELIA002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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