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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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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

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Burn Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ω-3 PUFA

Modular low fat diet (18%) including 9% as ω-3 PUFA

Group Type EXPERIMENTAL

ω-3 PUFA

Intervention Type DIETARY_SUPPLEMENT

The patients are fed as long as the clinically required with the randomly attributed enteral solution.

Low fat enteral diet

Modular low fat (18%)

Group Type ACTIVE_COMPARATOR

Low fat enteral diet

Intervention Type DIETARY_SUPPLEMENT

The patients are fed as long as the clinically required with the randomly attributed enteral solution

Interventions

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ω-3 PUFA

The patients are fed as long as the clinically required with the randomly attributed enteral solution.

Intervention Type DIETARY_SUPPLEMENT

Low fat enteral diet

The patients are fed as long as the clinically required with the randomly attributed enteral solution

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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modular preparation: 9% ω-3 of the total 18% fat modular diet

Eligibility Criteria

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Inclusion Criteria

\- adult \>16 years, burns \> 15% BSA, mechanical ventilation, next of kin consent

Exclusion Criteria

* absence of the above, absence of commitment to full treatment
* comorbidities (cancer, COPD, diabetes, liver failure (Child Pugh B and C)
* pregnancy

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No