MalnutritionNCT00538200
Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial
A study testing Oral Nutritional Supplements (Fortisip) and Dietary Advice in people with Malnutrition, run by University of Southampton at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Oral Nutritional Supplements (Fortisip) and Dietary Advice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2008to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Requirement for tube or parenteral nutrition
- Galactosemia
- Receiving current oral nutritional supplementation
- Palliative care
- Chronic renal disease requiring dialysis
- Liver failure
Show all 10Show fewer
- Malignancy
- Participation in other studies
- Bronchiectasis
- Those already under the care of a dietitian
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southampton University Hospitals NHS Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: 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.
- Conditions
- Malnutrition
- Being tested
- Oral Nutritional Supplements (Fortisip), Dietary Advice
- Keywords
- Nutrition, COPD
- Medical subject headings
- Malnutrition, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 AdviceOther
Standard dietary advice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Dietary Advice Receives: Other: Dietary Advice |
| 2 | Other | Supplements Receives: Dietary Supplement: Oral Nutritional Supplements (Fortisip) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is Quality of Life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startJan 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Marinos Elia, Professor, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538200
- Sponsor's protocol ID
- ELIA002
- Status last verified
- Dec 2014
- First submitted
- 4 Sep 2007
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Outcomes in Patients With COPD
- ClinicalTrials.gov ID
- NCT00538200
- Acronym / sponsor ID
- ELIA002
- Conditions
- Malnutrition
- Keywords
- Nutrition, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Study start
- Jan 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Dietary AdviceDietary Advice |
| 2 | Other | Dietary Supplement: Oral Nutritional Supplements (Fortisip)Supplements |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Requirement for tube or parenteral nutrition
- Galactosemia
- Receiving current oral nutritional supplementation
- Palliative care
- Chronic renal disease requiring dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | 2 |
| Dietary AdviceStandard dietary advice | Other | 1 |
Primary outcome
The primary outcome measure is Quality of Life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
Related trials for Malnutrition
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Not yet recruiting
Tolerance and Acceptability of an Oral Nutrition Supplement
Disease Related Malnutrition
RecruitingObservational study
Clinical and Laboratory Study of Methylmalonic Acidemia
Organic Acidemia, Methylmalonic Acidemia
RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Malnutrition, Infant, Malnutrition
Recruiting
Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis
Hepatic Cytolysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marinos Elia, Professor principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutritional Supplements (Fortisip) and Dietary Advice in people with Malnutrition, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is Quality of Life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.