NCT02189538

Effect of n-3 PUFA From Fish in Enteral Nutrition of Major Burn Patients

Effect of Omega-3 PUFA From Fish in Major Burn Patients. EFECTO DE ÁCIDOS GRASOS POLIINSATURADOS OMEGA 3 DERIVADOS DE ACEITE DE PESCADO, EN QUEMADOS GRAVES

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Centro Nacional de Quemados, Uruguay · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Studies have shown that burn patients may benefit from low fat diets, but there is still no strong data regarding the impact of fatty acid composition used for feeding. The trial test the hypothesis that the inclusion of omega-3 PUFA in a low fat diet may improve outcome. Prospective randomised controlled trial in adult patients admitted for burns \> 15% body surface area (BSA), and inhalation injury requiring mechanical ventilation and enteral nutrition. On admission randomization to receive a low-fat (18% energy as fat) modular enteral diet (LF-EN) and identical with the half of fat provided by fish oil (FO-EN). Study endpoints: mechanical ventilation time, inflammation (CRP), infectious and other complications, mortality until discharge. The study is planed as 2 parts: 1) preliminary study testing the feasibility of the study, 2) the study completed with information from the preliminary phase, both phases being randomised and controlled.

Detailed description

Randomisation within the first 24 hours of admission to 2 types of enteral feeds: 1) ω 3 PUFA (FO-EN) or 2) control solution which is the hospitals standard low 18% fat containing solution. The patients are fed as long as clinically required with the initial solution.

Conditions

• Burn Injury

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ω-3 PUFA	The patients are fed as long as the clinically required with the randomly attributed enteral solution.
DIETARY_SUPPLEMENT	Low fat enteral diet	The patients are fed as long as the clinically required with the randomly attributed enteral solution

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-12-01
• Completion: 2018-02-01
• First posted: 2014-07-14
• Last updated: 2017-02-15

Locations

1 site across 1 country: Uruguay