Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538200
• Other study ID #: ELIA002
• Status: Completed
• Phase: N/A
• First received: September 4, 2007
• Last updated: December 5, 2014
• Start date: January 2008
• Est. completion date: September 2011

Study information

• Verified date: December 2014
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Malnutrition
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Other:
• Dietary Advice
Standard dietary advice

Locations

Country	Name	City	State
United Kingdom	Southampton University Hospitals NHS Trust	Southampton	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Southampton	University Hospital Southampton NHS Foundation Trust.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is Quality of Life		6 months	No