The Effect of Selenium Supplementation Among Pediatric Patients With Burns

NCT ID: NCT00860379

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2019-12-31

Brief Summary

The selenium status of children with major burns is suboptimal which may increase the incidence of infection. Se requirements during critical illness are not known. Results from this investigation may provide a tool for recommending Se supplements during burn injury.

The hypothesis of this research is that Se supplementation will restore the depressed Se status among children with burn injuries. The secondary hypothesis is that Se status is related to the incidence of infection among pediatric patients with burns.

Detailed Description

Study Title: The effect of selenium supplementation among pediatric patients with burns

Primary Investigator: Maggie L. Dylewski, PhD, RD

Co-investigators: RL. Sheridan, MD; C Ryan, MD; K Prelack, PhD,RD; M Lydon, RN; J Weber, RN, BSN, CIC

Approved by: FDA (IND # 78963), Partners IRB (#2007-P-001176).

Funding: private grant from the Boston Burn Foundation

Background Information: Selenium, an essential dietary nutrient, is a component of glutathione peroxidase (an antioxidant) and thioredoxin reductase, an enzyme that regulates cytokine expression and thus plays a role in the immune system. Previous studies among adult burn patients showed that IV selenium supplementation was related to decreased infection and mortality. Please refer to the study protocol for further details.

Previous Research: We previously showed that children with burns (n = 20) > 20% TBSA had low plasma selenium values compared to reference data of healthy American children. Results from this study also found a significant relationship between plasma selenium and incidence of infections.

Study Design: Randomized, double-blind, placebo-controlled clinical trial

Specific Aims:

1. to determine the impact of supplemental selenium on plasma selenium, glutathione peroxidase activity, and urine selenium among pediatric patients with burns >20% total body surface area (TBSA) burn.

2. to determine the association between selenium supplementation, biomarkers of Se status and indicators of stress and infection.

Subjects: N = 75 pediatric patients with burns.

Inclusion criteria:

• Between 1 and 18 years of age admitted to Shriners Burns Hospital
• TBSA burn of > 20%
• Existing IV catheter
• Enrolled into study within 3 weeks of burn injury

Treatment:

All subjects will be randomized into 1 of 3 groups and receive the treatment for 8 weeks, until 95% wound closure, or until central venous catheter access is discontinued.

1. Placebo (IV 0.9% sodium chloride)

2. 2 mcg/kg/day IV Selenium

3. 4 mcg/kg/day IV Selenium

Biological sample collection:

• 4 mL or 8 mL (8 every other week) of plasma once a week
• 24-hour urine collection once a week

Sample analyses:

• Samples will be frozen until analyses
• Samples will be sent to the outside lab for analyses.
• Plasma will also be sent to Massachusetts General Hospital every other week for plasma selenium analysis (to assess for toxicity)

Primary outcome measures:

• Plasma selenium
• Plasma glutathione peroxidase
• Urine selenium

Secondary outcome measures:

• occurrence of pneumonia or infection (bacterial or fungal) in the wound, blood, or urine

Risks:

• Supplement doses were determined using data from previous studies, current recommended dietary allowance (RDA) and upper tolerable limits, American Society for Parenteral and Enteral Nutrition (ASPEN) guidelines for parenteral selenium, and dietary data recorded from our previous study. According to reference weights (NHANES III) supplement doses do not exceed the upper tolerable limits for children.
• Selenium toxicity is rare. However plasma will be assessed every other week for selenium levels.

Monitoring and Quality Assurance:

• All subjects will be monitored for any treatment-related adverse events for 2 weeks following discontinuation of the study therapy
• Any adverse events will be reported to the Partners Human Research Committee and the FDA per the guidelines.

An independent Data Safety Monitoring Board, consisting of 4 knowledgeable staff members, will meet 2 times per year to monitor the data for safety.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV saline as placebo

Selenium1

Subject will receive 2 ug/kg of IV selenium per day

Group Type: EXPERIMENTAL

Selenium1

Intervention Type: DRUG

2 ug/kg

Selenium2

Subject will receive 4 ug/kg of IV selenium per day

Group Type: EXPERIMENTAL

Selenium2

Intervention Type: DRUG

4 ug/kg

Interventions

Selenium1

2 ug/kg

Intervention Type: DRUG

Selenium2

4 ug/kg

Intervention Type: DRUG

Placebo

IV saline as placebo

Intervention Type: DRUG

Other Intervention Names

saline

Eligibility Criteria

Inclusion Criteria

• Between 1 and 18 years of age admitted to Shriners Burns Hospital
• TBSA burn of > 20%
• Existing IV catheter
• Enrolled into study within 3 weeks of burn injury

Exclusion Criteria

• < 1 year or > 18 years of age
• < 20% TBSA burn
• No existing IV catheter
• Pre-existing or acute renal disease (creatine > 1.5 mg/dl)
• Pre-existing or acute liver disease (bilirubin > 3)
• Pre-existing or acute thyroid disorders
• Cancer
• AIDS
• Pregnancy (as determined by routine admission labs)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shriners Hospitals for Children

OTHER

Sponsor Role: lead

Responsible Party

Maggie Dylewski

PhD,RD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maggie L Dylewski, PhD,RD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children

Locations

Shriners Hospitals for Children

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2007-P-001176

Identifier Type: -

Identifier Source: org_study_id