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The Effect of Selenium Supplementation Among Pediatric Patients With Burns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00860379
Recruitment Status : Terminated (Due to a shift in primary responsibilities, the PI was not longer able to enroll subjects.)
First Posted : March 12, 2009
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Maggie Dylewski, Shriners Hospitals for Children

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.


Condition or disease Intervention/treatment Phase
Burns Drug: Selenium1 Drug: Selenium2 Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Selenium Supplementation Among Pediatric Patients With Burns
Study Start Date : January 2009
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
IV saline as placebo
Other Name: 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




Primary Outcome Measures :
  1. plasma selenium, plasma glutathione peroxidase, urine selenium [ Time Frame: weekly ]

Secondary Outcome Measures :
  1. infection [ Time Frame: daily ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860379


Locations
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United States, Massachusetts
Shriners Hospitals for Children
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
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Principal Investigator: Maggie L Dylewski, PhD,RD Shriners Hospitals for Children
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Responsible Party: Maggie Dylewski, PhD,RD, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00860379    
Other Study ID Numbers: 2007-P-001176
First Posted: March 12, 2009    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances