Burn Micronutrient Repletion Pilot Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Burn Micronutrient Repletion Pilot Study: Characterizing Relationships Between Vitamin and Mineral Supplementation and Health Outcomes of Adult Burn Patients|
- wound healing [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- rate of infection [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- number of days in hospital [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- number of days in Intensive Care Unit [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- number of days on ventilator [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- mortality rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- hospital charges [ Time Frame: 14 days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: Vitamin and mineral supplementation
Intravenous micronutrient solution or an oral micronutrient supplementation twice per day for 14 days. Treatment is determined by percent total body surface area burned.
Dietary Supplement: Vitamin and Mineral supplementation
IV - 2x per day given 2 - 12 hours apart. A.M. solution - Infuvite multivitamin with minerals, Selenium 200mcg, Zinc 30mg, Vitamin B1 100mg and Vitamin C 500mg. P.M. solution - Cuperic Chloride 9mg (provides Copper 3.36mg) and Vitamin C 500mg. Each fluid solution will run for 4 hours.
Enteral (oral) 2 x per day given 2 - 12 hours apart. A.M. dose - multivitamin with minerals, Selenium 200mcg, Zinc 30mg, Vitamin B1 100mg and Vitamin C 500mg. P.M. dose - Copper 4mg and Vitamin C 500mg.
No Intervention: Control
current vitamin regimen as listed on the Memorial medical Center Order Set for burn unit admission.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879723
|United States, Illinois|
|Memorial Medical Center|
|Springfield, Illinois, United States, 62702|
|Principal Investigator:||Michael W Neumeister, MD||Southern Illinois University School of Medicine|