PneumoniaPhase 3NCT01477723
Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients
A Phase 3 study testing Experimental Oral Nutritional Supplement in people with Pneumonia, run by Abbott Nutrition at 14 sites in 2 countries.
Trial summary
Study objectives are to verify the loss of lean mass during a hospital stay in a group of older patients; to evaluate the effects of consuming a high-calorie complete and balanced oral nutritional supplement; to collect post-discharge information. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Experimental Oral Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Oct 2011to Nov 2012
- Phase
- Phase 3
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 55 years of age.
- Admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases.
- Anticipated length of hospital stay of at least 3 days.
- Ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization.
- Able to consume foods and beverages orally.
Who cannot join
- Unstable heart failure which requires ICU admission.
- Severe respiratory disease requiring long-term, continuous oxygen therapy.
- Diabetes.
- Impaired renal function.
- Impaired liver function.
- Cancer.
Show all 19Show fewer
- Hospitalized for two or more days in past 4 weeks.
- Requires intubation or tube feeding.
- Expected to be transferred to an advanced care unit.
- Body mass index of ≥ 40 kg/m2.
- Active tuberculosis.
- Ascites or severe edema.
- Acute Hepatitis or HIV.
- Disorder of gastrointestinal tract.
- Dementia;brain metastases, eating disorder, significant neurological, psychiatric disorder, other psychological condition.
- Medication/dietary supplements/substances that could modulate metabolism or weight.
- Partial or full artificial lower limb.
- Allergy or intolerance to any of the ingredients in the study products.
- Procedure using iodine-based contrast media within 7 days prior to hospitalization; or, anticipated to need procedure using iodine-based contrast media within 3 days after hospital admission.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Mount Carmel West Hospital
Columbus, Ohio, 43222
The University of Texas Medical Branch
Galveston, Texas, 77555-1144
Central Maine Medical Center
Lewiston, Maine, 04240
Horizon Research Group Inc
Mobile, Alabama, 36608
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
William Beaumont Hospital
Royal Oak, Michigan, 48073
Salem VA Medical Center
Salem, Virginia, 24153
Springfield Clinic
Springfield, Illinois, 62703
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Puerto Rico2 sites
Hospital HIMA San Pablo
Bayamón, Puerto Rico, 00959
Manati Medical Center
Manati, Puerto Rico, 00647
About this study
Official title: Evaluation of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
Study objectives are to verify the loss of lean mass during a hospital stay in a group of older patients; to evaluate the effects of consuming a high-calorie complete and balanced oral nutritional supplement; to collect post-discharge information.
- Conditions
- Pneumonia
- Being tested
- Experimental Oral Nutritional Supplement
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Oral Nutritional SupplementOther
Experimental ONS orally Two 8 fl oz servings/day
| Study group | Role | What they receive |
|---|---|---|
| Experimental Oral Nutrition Supplement | Experimental | Experimental ONS orally Two 8 fl oz servings/day Receives: Other: Experimental Oral Nutritional Supplement |
| No Product | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Lean Mass
Measured: baseline to day 30
Secondary outcomes (3)
Body Weight
Measured: baseline to day 30
Body Mass Index
Measured: baseline to day 30
Activities of daily living
Measured: baseline to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vikkie Mustad, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477723
- Sponsor's protocol ID
- BK33
- Status last verified
- Feb 2013
- First submitted
- 19 Nov 2011
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
- ClinicalTrials.gov ID
- NCT01477723
- Acronym / sponsor ID
- BK33
- Conditions
- Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Nov 2011 (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.
Study objectives are to verify the loss of lean mass during a hospital stay in a group of older patients; to evaluate the effects of consuming a high-calorie complete and balanced oral nutritional supplement; to collect post-discharge information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Oral Nutrition Supplement | Experimental | Other: Experimental Oral Nutritional SupplementExperimental ONS orally Two 8 fl oz servings/day |
| No Product | No intervention | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 55 years of age.
- Admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases.
- Anticipated length of hospital stay of at least 3 days.
- Ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization.
- Able to consume foods and beverages orally.
Key exclusion criteria (19 listed)
- Unstable heart failure which requires ICU admission.
- Severe respiratory disease requiring long-term, continuous oxygen therapy.
- Diabetes.
- Impaired renal function.
- Impaired liver function.
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 |
|---|---|---|
| Experimental Oral Nutritional SupplementExperimental ONS orally Two 8 fl oz servings/day | Other | Experimental Oral Nutrition Supplement |
Primary outcome
Leg Lean Mass
Time frame: baseline to day 30
3 secondary outcomes
Body Weight
Time frame: baseline to day 30
Body Mass Index
Time frame: baseline to day 30
Activities of daily living
Time frame: baseline to day 30
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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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.
Vikkie Mustad, PhD study chair
Abbott Nutrition
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental Oral Nutritional Supplement in people with Pneumonia, run by Abbott Nutrition at 14 sites in 2 countries.
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 5 inclusion and 19 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: stopped early, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Puerto Rico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Leg Lean Mass (time frame: baseline to day 30). 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 15 Feb 2013.