Chronic Obstructive Pulmonary Disease (COPD) Nutrition Su... | NCT00538200

Studies
Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial

NCT00538200

Sponsor

University of Southampton

Status

Completed

Last Update Posted

Dec 8, 2014Estimated

Enrollment

85Actual

Phase

Not Applicable

Conditions

Malnutrition

Interventions

Oral Nutritional Supplements (Fortisip)
Dietary Advice

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Sep 4, 2007

First Submission Date that Met QC Criteria

Oct 1, 2007

First Posted Date

Oct 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2014

Last Update Posted Date

Dec 8, 2014Estimated

Name	Class
University Hospital Southampton NHS Foundation Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Dietary Advice	Other: Dietary Advice
2	Other	Supplements	Dietary Supplement: Oral Nutritional Supplements (Fortisip)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marinos Elia, Professor	University of Southampton	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southampton University Hospitals NHS Trust		Southampton	Hampshire	SO16 6YD	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019587	Dietary Supplements
D015596	Nutrition Assessment

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided