The Effect of Selenium Supplementation Among Pediatric Patients With Burns

July 9, 2021 updated by: Maggie Dylewski, Shriners Hospitals for Children

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Shriners Hospitals for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
IV saline as placebo
Other Names:
  • saline
Experimental: Selenium1
Subject will receive 2 ug/kg of IV selenium per day
Drug: Selenium1
2 ug/kg
Experimental: Selenium2
Subject will receive 4 ug/kg of IV selenium per day
Drug: Selenium2
4 ug/kg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma Selenium
Time Frame: Average plasma selenium calculated over 8 weeks, assessed weekly.
plasma selenium of all subjects was assessed
Average plasma selenium calculated over 8 weeks, assessed weekly.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shriners Hospitals for Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maggie L Dylewski, PhD,RD, Shriners Hospitals for Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007-P-001176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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