NCT01448135

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness
• Enteral Feeding

Interventions

Type	Name	Description
OTHER	VITAL AF	Semi-elemental, high protein, and high omega-3 fish oil enteral formula
OTHER	Osmolite 1.2	High protein enteral formula

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2011-10-07
• Last updated: 2015-06-23

Locations

1 site across 1 country: United States