Burn Micronutrient Repletion Pilot Study
August 25, 2015 updated by: Southern Illinois University
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Springfield, Illinois, United States, 62702
- Memorial Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
rate of infection
Time Frame: 14 days
|
14 days
|
|
number of days in hospital
Time Frame: 14 days
|
14 days
|
|
number of days in Intensive Care Unit
Time Frame: 14 days
|
14 days
|
|
number of days on ventilator
Time Frame: 14 days
|
14 days
|
|
mortality rate
Time Frame: 14 days
|
14 days
|
|
hospital charges
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael W Neumeister, MD, Southern Illinois University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEU-SIUSOM-09-002-1
- SCRIHS 08-105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.