Burn Micronutrient Repletion Pilot Study
2 other identifiers
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2009
CompletedFirst Posted
Study publicly available on registry
April 10, 2009
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedAugust 26, 2015
August 1, 2015
1 year
April 9, 2009
August 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
wound healing
14 days
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Vitamin and mineral supplementation
EXPERIMENTALIntravenous micronutrient solution or an oral micronutrient supplementation twice per day for 14 days. Treatment is determined by percent total body surface area burned.
Control
NO INTERVENTIONcurrent vitamin regimen as listed on the Memorial medical Center Order Set for burn unit admission.
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients who present at the burn unit with TBSA \> 1%
You may not qualify if:
- less than 19 years old
- chronic renal failure
- chronic liver failure
- pregnancy or lactation
- patients who require parenteral nutrition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Southern Illinois Universitylead
- Memorial Medical Centercollaborator
Study Sites (1)
Memorial Medical Center
Springfield, Illinois, 62702, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael W Neumeister, MD
Southern Illinois University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2009
First Posted
April 10, 2009
Study Start
August 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
August 26, 2015
Record last verified: 2015-08