Skip to content

Burn Micronutrient Repletion Pilot Study

Burn Micronutrient Repletion Pilot Study: Characterizing Relationships Between Vitamin and Mineral Supplementation and Health Outcomes of Adult Burn Patients

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00879723
Enrollment
28
Registered
2009-04-10
Start date
2010-08-31
Completion date
2011-08-31
Last updated
2015-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn

Keywords

post-burn recovery, oxidative stress, micronutrient protocol

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.

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.

Sponsors

Memorial Medical Center
CollaboratorOTHER
Southern Illinois University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
wound healing14 days

Secondary

MeasureTime frame
number of days in hospital14 days
number of days in Intensive Care Unit14 days
rate of infection14 days
mortality rate14 days
hospital charges14 days
number of days on ventilator14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026