Critical IllnessNCT01448135
Tolerance and Efficacy of a Predigested, High Protein, High Omega 3 Fat Enteral Feeding Formula Versus a Standard Formula In Multiple Intensive Care Unit Settings
A study testing VITAL AF and Osmolite 1.2 in people with Critical Illness and Enteral Feeding, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this pilot study is to assess the efficacy, safety and tolerance profile of the enteral feeding product VITAL AF (a semi-elemental, high protein, and high omega-3 fish oil) when compared to Osmolite 1.2, a standard feeding product in critically ill and/or post surgical patients in the intensive care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Enteral Feeding
- What is being tested?
- VITAL AF and Osmolite 1.2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Nov 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject requires enteral tube feeding as sole source of nourishment
- Subject, or subject's legally acceptable representative (LAR), has provided voluntarily and informed consent form, as deemed appropriate and approved by the Columbia University Medical Center Institutional Review Board
- Subject is ≥ 18 years of age
- Subject is male or non-pregnant female at least six weeks postpartum and non-lactating females of childbearing potential will be required to confirm non-pregnancy status with a pregnancy test at screening
- Subject has an initial APACHE II score less than or equal to 24
Who cannot join
- Subject requires parenteral nutrition
- Subject is acutely impacted or constipated
- Subject has intestinal obstruction
- Subject is too hemodynamically unstable for enteral feeding
- Subject has an allergy or intolerance to any ingredient in the study product by documentation or verbal report by subject or subject's LAR
- Subject is participating in a non-Abbott approved concomitant trial
- Subject has gastrointestinal disease, including acute pancreatitis, active gastrointestinal bleeding, acute inflammatory bowel disease, or has undergone intestinal surgery within the past month
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork-Presbyterian Hospital at Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Pilot Study Evaluating the Efficacy, Tolerance and Safety of VITAL AF (Semi Elemental, High Protein, High Omega 3 Fat Enteral Formula) Versus Osmolite 1.2 (High Protein Enteral Formula) in Multiple ICU Settings (Medical, Surgical, Cardiothoracic)
The purpose of this pilot study is to assess the efficacy, safety and tolerance profile of the enteral feeding product VITAL AF (a semi-elemental, high protein, and high omega-3 fish oil) when compared to Osmolite 1.2, a standard feeding product in critically ill and/or post surgical patients in the intensive care unit (ICU). If enough patients are recruited, inferences about impact on outcomes may also be drawn.
- Conditions
- Critical Illness, Enteral Feeding
- Being tested
- VITAL AF, Osmolite 1.2
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VITAL AFOther
Semi-elemental, high protein, and high omega-3 fish oil enteral formula
Osmolite 1.2Other
High protein enteral formula
| Study group | Role | What they receive |
|---|---|---|
| Vital AF | Experimental | Not described Receives: Other: VITAL AF |
| Osmolite 1.2 | Active comparator | Not described Receives: Other: Osmolite 1.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved tolerance to enteral (tube) feeding
Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.
Measured: Baseline and 21 Days
Secondary outcomes (2)
Improved delivery of prescribed calories
Measurement of volume of feeding product actually delivered to patient is part of the daily flow-sheet data.
Measured: Baseline and 21 Days
Decreased incidence of complications
Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.
Measured: Baseline and 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition
- Responsible party
- Principal investigator, Ira Jay Goldberg, Columbia University
- Investigators
- Ira J Goldberg, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448135
- Sponsor's protocol ID
- AAAI1205
- Other IDs
- ANUS1015
- Status last verified
- Jan 2014
- First submitted
- 3 Oct 2011
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Seres DS, Ippolito PR. Pilot study evaluating the efficacy, tolerance and safety of a peptide-based enteral formula versus a high protein enteral formula in multiple ICU settings (medical, surgical, cardiothoracic). Clin Nutr. 2017 Jun;36(3):706-709. doi: 10.1016/j.clnu.2016.04.016. Epub 2016 Apr 26.
PubMed 27161892
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Efficacy, Tolerance and Safety of VITAL AF (Semi Elemental, High Protein, High Omega 3 Fat Enteral Formula) Versus Osmolite 1.2 (High Protein Enteral Formula) in Multiple ICU Settings (Medical, Surgical, Cardiothoracic)
- ClinicalTrials.gov ID
- NCT01448135
- Acronym / sponsor ID
- AAAI1205
- Conditions
- Critical Illness, Enteral Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Abbott Nutrition
- Study start
- Oct 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Oct 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.
The purpose of this pilot study is to assess the efficacy, safety and tolerance profile of the enteral feeding product VITAL AF (a semi-elemental, high protein, and high omega-3 fish oil) when compared to Osmolite 1.2, a standard feeding product in critically ill and/or post surgical patients in the intensive care unit (ICU). If enough patients are recruited, inferences about impact on outcomes may also be drawn.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vital AF | Experimental | Other: VITAL AF |
| Osmolite 1.2 | Active comparator | Other: Osmolite 1.2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject requires enteral tube feeding as sole source of nourishment
- Subject, or subject's legally acceptable representative (LAR), has provided voluntarily and informed consent form, as deemed appropriate and approved by the Columbia University Medical Center Institutional Review Board
- Subject is ≥ 18 years of age
- Subject is male or non-pregnant female at least six weeks postpartum and non-lactating females of childbearing potential will be required to confirm non-pregnancy status with a pregnancy test at screening
- Subject has an initial APACHE II score less than or equal to 24
Key exclusion criteria (7 listed)
- Subject requires parenteral nutrition
- Subject is acutely impacted or constipated
- Subject has intestinal obstruction
- Subject is too hemodynamically unstable for enteral feeding
- Subject has an allergy or intolerance to any ingredient in the study product by documentation or verbal report by subject or subject's LAR
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 |
|---|---|---|
| VITAL AFSemi-elemental, high protein, and high omega-3 fish oil enteral formula | Other | Vital AF |
| Osmolite 1.2High protein enteral formula | Other | Osmolite 1.2 |
Primary outcome
Improved tolerance to enteral (tube) feeding
Time frame: Baseline and 21 Days
Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.
2 secondary outcomes
Improved delivery of prescribed calories
Time frame: Baseline and 21 Days
Decreased incidence of complications
Time frame: Baseline and 21 Days
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 23 Jun 2015.
- Derived from this study: PubMed 27161892Seres DS, Ippolito PR. Pilot study evaluating the efficacy, tolerance and safety of a peptide-based enteral formula versus a high protein enteral formula in multiple ICU settings (medical, surgical, cardiothoracic). Clin Nutr. 2017 Jun;36(3):706-709. doi: 10.1016/j.clnu.2016.04.016. Epub 2016 Apr 26.
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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.
Ira J Goldberg, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VITAL AF and Osmolite 1.2 in people with Critical Illness and Enteral Feeding, run by Columbia University at 1 site in United States.
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 7 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 23 Jun 2015. 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 States. 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?
Improved tolerance to enteral (tube) feeding (time frame: Baseline and 21 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01448135, which also lists 1 linked publication.
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 23 Jun 2015.