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Burn Micronutrient Repletion Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Memorial Medical Center
Information provided by (Responsible Party):
Michael Neumeister, MD, Southern Illinois University
ClinicalTrials.gov Identifier:
NCT00879723
First received: April 9, 2009
Last updated: September 7, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Burn
 Dietary Supplement: Vitamin and Mineral supplementation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Burn Micronutrient Repletion Pilot Study: Characterizing Relationships Between Vitamin and Mineral Supplementation and Health Outcomes of Adult Burn Patients

Resource links provided by NLM:

MedlinePlus related topics: Burns Minerals
U.S. FDA Resources

Further study details as provided by Southern Illinois University:

Primary Outcome Measures:
  • wound healing [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rate of infection [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • number of days in hospital [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • number of days in Intensive Care Unit [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • number of days on ventilator [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • mortality rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • hospital charges [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879723

Locations
United States, Illinois
Memorial Medical Center
Springfield, Illinois, United States, 62702
Sponsors and Collaborators
Southern Illinois University
Memorial Medical Center
Investigators
Principal Investigator: Michael W Neumeister, MD Southern Illinois University School of Medicine
  More Information

No publications provided

Responsible Party: Michael Neumeister, MD, Associate Professor, Southern Illinois University
ClinicalTrials.gov Identifier: NCT00879723     History of Changes
Other Study ID Numbers: NEU-SIUSOM-09-002-1, SCRIHS 08-105
Study First Received: April 9, 2009
Last Updated: September 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Southern Illinois University:
post-burn recovery
oxidative stress
micronutrient protocol

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Micronutrients
Trace Elements
 Vitamins
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013