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

NCT02189538 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-02-15

No results posted yet for this study

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.

Conditions

  • Burn Injury

Interventions

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

Sponsors & Collaborators

  • Centro Nacional de Quemados, Uruguay

    lead OTHER

Principal Investigators

  • Serrana Tihista, RD · Universidad de la República Oriental del Uruguay

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-12-31
Completion
2018-02-28

Countries

  • Uruguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02189538 on ClinicalTrials.gov