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Completed

NCT Number: NCT00538200

Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial

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.

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Key information

Conditions

Malnutrition Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southampton University Hospitals NHS Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Nutritional Supplements (Fortisip)

Dietary Supplement

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.

Dietary Advice

Other

Standard dietary advice

Primary outcomes

  1. The primary outcome measure is Quality of Life

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Collaborators

  • University Hospital Southampton NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 2, 2007
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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