NCT01448135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

June 23, 2015

Status Verified

January 1, 2014

Enrollment Period

3.1 years

First QC Date

October 3, 2011

Last Update Submit

June 22, 2015

Conditions

Critical IllnessEnteral Feeding

Outcome Measures

Primary Outcomes (1)

  • Improved tolerance to enteral (tube) feeding

    Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.

    Baseline and 21 Days

Secondary Outcomes (2)

  • Improved delivery of prescribed calories

    Baseline and 21 Days

  • Decreased incidence of complications

    Baseline and 21 Days

Study Arms (2)

Vital AF

EXPERIMENTAL
Other: VITAL AF

Osmolite 1.2

ACTIVE COMPARATOR
Other: Osmolite 1.2

Interventions

VITAL AFOTHER

Semi-elemental, high protein, and high omega-3 fish oil enteral formula

Vital AF
Osmolite 1.2OTHER

High protein enteral formula

Osmolite 1.2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NewYork-Presbyterian Hospital at Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 27161892DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ira J Goldberg, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dickinson W. Richards, Jr. Professor of Medicine

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 7, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

June 23, 2015

Record last verified: 2014-01

Locations

US(1)