Burn Micronutrient Repletion Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Memorial Medical Center
Information provided by (Responsible Party):
Michael Neumeister, MD, Southern Illinois University
ClinicalTrials.gov Identifier:
NCT00879723
First received: April 9, 2009
Last updated: September 7, 2011
Last verified: September 2011

April 9, 2009
September 7, 2011
August 2010
August 2011   (final data collection date for primary outcome measure)
wound healing [ Time Frame: 14 days ] [ Designated as safety issue: No ]
rate of infection, # of days in hospital, # of days in Intensive Care Unit, # of days on ventilator, hospital cost, mortality rate and wound healing [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00879723 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Burn Micronutrient Repletion Pilot Study
Burn Micronutrient Repletion Pilot Study: Characterizing Relationships Between Vitamin and Mineral Supplementation and Health Outcomes of Adult Burn Patients

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Burn
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.

  • 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.
    Intervention: Dietary Supplement: Vitamin and Mineral supplementation
  • No Intervention: Control
    current vitamin regimen as listed on the Memorial medical Center Order Set for burn unit admission.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00879723
NEU-SIUSOM-09-002-1, SCRIHS 08-105
No
Michael Neumeister, MD, Southern Illinois University
Southern Illinois University
Memorial Medical Center
Principal Investigator: Michael W Neumeister, MD Southern Illinois University School of Medicine
Southern Illinois University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP