Burn Micronutrient Repletion Pilot Study

Southern Illinois University

Status and phase: Completed; Phase 1

Conditions: Burn

Treatments: Dietary Supplement: Vitamin and Mineral supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT00879723

SCRIHS 08-105

NEU-SIUSOM-09-002-1

Details and patient eligibility

About

Burn injury patients undergo a series of metabolic changes that, if untreated, could lead to reduced health outcomes. Nutrition is thought to play a vital role in post-burn recovery. The research team developed a novel vitamin and mineral supplementation protocol based on current scientific literature. The study will test the hypothesis that the novel vitamin and mineral supplement regimen will improve adult patient recovery from burn injury.

Full description

Burn injury patients undergo a series of metabolic events that, if untreated, could lead to severe physical impairment and even death. Antioxidants minimize free radical damage by neutralizing the chemical reaction as well as promoting cellular repair. Currently there is no consistent protocol for micronutrient repletion in adult burn patients. The aim of this study is to evaluate the effectiveness of the current vitamin regimen in comparison to the novel vitamin and mineral supplementation protocol developed by the research team. Dosages for oral and intravenous supplementation are based on current literature. The combination of intravenous and enteral treatment is important due to gastrointestinal mucosal swelling related to post-burn fluid resuscitation. Measurable health outcomes will include rate of infection, length of hospital stay, mortality rate, hospital cost, number of days in intensive care unit, number of ventilator-dependent days and wound healing. The investigators hypothesize that use of the novel vitamin and mineral supplement regimen will improve adult burn patient outcomes.

Enrollment: 28 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who present at the burn unit with TBSA > 1%

Exclusion criteria

• less than 19 years old
• chronic renal failure
• chronic liver failure
• pregnancy or lactation
• patients who require parenteral nutrition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Vitamin and mineral supplementation

Experimental group

Description:

Intravenous micronutrient solution or an oral micronutrient supplementation twice per day for 14 days. Treatment is determined by percent total body surface area burned.

Treatment:

Dietary Supplement: Vitamin and Mineral supplementation

Control

No Intervention group

Description:

current vitamin regimen as listed on the Memorial medical Center Order Set for burn unit admission.