Burn Micronutrient Repletion Pilot Study
Primary Purpose
Burn
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin and Mineral supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Burn focused on measuring post-burn recovery, oxidative stress, micronutrient protocol
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
Sites / Locations
- Memorial Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vitamin and mineral supplementation
Control
Arm Description
Intravenous micronutrient solution or an oral micronutrient supplementation twice per day for 14 days. Treatment is determined by percent total body surface area burned.
current vitamin regimen as listed on the Memorial medical Center Order Set for burn unit admission.
Outcomes
Primary Outcome Measures
wound healing
Secondary Outcome Measures
rate of infection
number of days in hospital
number of days in Intensive Care Unit
number of days on ventilator
mortality rate
hospital charges
Full Information
NCT ID
NCT00879723
First Posted
April 9, 2009
Last Updated
August 25, 2015
Sponsor
Southern Illinois University
Collaborators
Memorial Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00879723
Brief Title
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
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern Illinois University
Collaborators
Memorial Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn
Keywords
post-burn recovery, oxidative stress, micronutrient protocol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin and mineral supplementation
Arm Type
Experimental
Arm Description
Intravenous micronutrient solution or an oral micronutrient supplementation twice per day for 14 days. Treatment is determined by percent total body surface area burned.
Arm Title
Control
Arm Type
No Intervention
Arm Description
current vitamin regimen as listed on the Memorial medical Center Order Set for burn unit admission.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin and Mineral supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
wound healing
Time Frame
14 days
Secondary Outcome Measure Information:
Title
rate of infection
Time Frame
14 days
Title
number of days in hospital
Time Frame
14 days
Title
number of days in Intensive Care Unit
Time Frame
14 days
Title
number of days on ventilator
Time Frame
14 days
Title
mortality rate
Time Frame
14 days
Title
hospital charges
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Neumeister, MD
Organizational Affiliation
Southern Illinois University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Burn Micronutrient Repletion Pilot Study
We'll reach out to this number within 24 hrs