Burn Micronutrient Repletion Pilot Study

Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879723
• Other study ID #: NEU-SIUSOM-09-002-1
• Secondary ID: SCRIHS 08-105
• Status: Completed
• Phase: Phase 1
• First received: April 9, 2009
• Last updated: August 25, 2015
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2015
• Source: Southern Illinois University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn
• Burns

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Medical Center	Springfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Southern Illinois University	Memorial Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing		14 days	No
Secondary	rate of infection		14 days	No
Secondary	number of days in hospital		14 days	No
Secondary	number of days in Intensive Care Unit		14 days	No
Secondary	number of days on ventilator		14 days	No
Secondary	mortality rate		14 days	No
Secondary	hospital charges		14 days	No