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Burn Micronutrient Repletion Pilot Study

Phase 1
Completed
Conditions
Burn
Interventions
Dietary Supplement: Vitamin and Mineral supplementation
Registration Number
NCT00879723
Lead Sponsor
Southern Illinois University
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
28
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Vitamin and mineral supplementationVitamin and Mineral supplementationIntravenous micronutrient solution or an oral micronutrient supplementation twice per day for 14 days. Treatment is determined by percent total body surface area burned.
Primary Outcome Measures
NameTimeMethod
wound healing14 days
Secondary Outcome Measures
NameTimeMethod
rate of infection14 days
number of days in hospital14 days
number of days on ventilator14 days
number of days in Intensive Care Unit14 days
mortality rate14 days
hospital charges14 days

Trial Locations

Locations (1)

Memorial Medical Center

🇺🇸

Springfield, Illinois, United States

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