Clinical trial NCT00879723: Burn Micronutrient Repletion Pilot Study
Official title: Burn Micronutrient Repletion Pilot Study: Characterizing Relationships Between Vitamin and Mineral Supplementation and Health Outcomes of Adult Burn Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Burn
Keywords: post-burn recovery
oxidative stress
micronutrient protocol
Lead sponsor: Southern Illinois University
Sponsor class: OTHER
Collaborators: name: Memorial Medical Center
First posted: 2009-04-10
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: wound healing
timeFrame: 14 days
Secondary outcomes:
measure: rate of infection
timeFrame: 14 days
measure: number of days in hospital
timeFrame: 14 days
measure: number of days in Intensive Care Unit
timeFrame: 14 days
measure: number of days on ventilator
timeFrame: 14 days
measure: mortality rate
timeFrame: 14 days
measure: hospital charges
timeFrame: 14 days
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
Study officials:
affiliation: Southern Illinois University School of Medicine
name: Michael W Neumeister, MD
role: PRINCIPAL_INVESTIGATOR
References: