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.

Study Overview

• Status: Completed
• Conditions: Burn
• Intervention / Treatment: Dietary supplement: Vitamin and Mineral supplementation

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Springfield, Illinois, United States, 62702
      • Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
wound healing	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
rate of infection	14 days
number of days in hospital	14 days
number of days in Intensive Care Unit	14 days
number of days on ventilator	14 days
mortality rate	14 days
hospital charges	14 days

Collaborators and Investigators

• Sponsor: Southern Illinois University
• Collaborators: Memorial Medical Center
• Investigators: Principal Investigator: Michael W Neumeister, MD, Southern Illinois University School of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: April 9, 2009
• First Submitted That Met QC Criteria: April 9, 2009
• First Posted (Estimate): April 10, 2009

Study Record Updates

• Last Update Posted (Estimate): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 25, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: oxidative stress; post-burn recovery; micronutrient protocol
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: NEU-SIUSOM-09-002-1; SCRIHS 08-105