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| Sponsored by: |
Shriners Hospitals for Children |
|---|---|
| Information provided by: | Shriners Hospitals for Children |
| ClinicalTrials.gov Identifier: | NCT00860379 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Burns |
Drug: IV selenium Drug: Saline |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
| Official Title: | The Effect of Selenium Supplementation Among Pediatric Patients With Burns |
| Estimated Enrollment: | 75 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo: Placebo Comparator |
Drug: Saline
IV saline as placebo
|
|
Selenium1: Experimental
2 ug/kg
|
Drug: IV selenium
2 ug/kg
|
|
Selenium2: Experimental
4 ug/kg
|
Drug: IV selenium
4 ug/kg
|
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Maggie L Dylewski, PhD,RD | 617-371-4783 | mdylewski@shrinenet.org |
| United States, Massachusetts | |
| Shriners Hospitals for Children | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Maggie L Dylewski, PhD,RD 617-371-4783 mdylewski@shrinenet.org | |
| Principal Investigator: | Maggie L Dylewski, MS,PhD | Shriners Hospitals for Children |
More Information
| Responsible Party: | Shriners Hospitals for Children - Boston ( Maggie L. Dylewski, PhD,RD ) |
| Study ID Numbers: | 2007-P-001176 |
| Study First Received: | March 11, 2009 |
| Last Updated: | March 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00860379 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Burns Selenium Antioxidants Wounds and Injuries |
Disorders of Environmental Origin Trace Elements Micronutrients |
|
Burns Selenium Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs |
Wounds and Injuries Disorders of Environmental Origin Trace Elements Micronutrients Protective Agents Pharmacologic Actions |
