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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01448135
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : June 23, 2015
Abbott Nutrition
Information provided by (Responsible Party):
Ira Jay Goldberg, Columbia University

Brief 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 unit (ICU). If enough patients are recruited, inferences about impact on outcomes may also be drawn.

Condition or disease Intervention/treatment Phase
Critical Illness Enteral Feeding Other: VITAL AF Other: Osmolite 1.2 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
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)
Study Start Date : October 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: Vital AF Other: VITAL AF
Semi-elemental, high protein, and high omega-3 fish oil enteral formula
Active Comparator: Osmolite 1.2 Other: Osmolite 1.2
High protein enteral formula

Primary Outcome Measures :
  1. Improved tolerance to enteral (tube) feeding [ Time Frame: Baseline and 21 Days ]
    Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.

Secondary Outcome Measures :
  1. Improved delivery of prescribed calories [ Time Frame: Baseline and 21 Days ]
    Measurement of volume of feeding product actually delivered to patient is part of the daily flow-sheet data.

  2. Decreased incidence of complications [ Time Frame: Baseline and 21 Days ]
    Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01448135

United States, New York
NewYork-Presbyterian Hospital at Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Abbott Nutrition
Principal Investigator: Ira J Goldberg, MD Columbia University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ira Jay Goldberg, Dickinson W. Richards, Jr. Professor of Medicine, Columbia University Identifier: NCT01448135     History of Changes
Other Study ID Numbers: AAAI1205
ANUS1015 ( Other Grant/Funding Number: ABBOTT Nutrition )
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: January 2014

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes