- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00536822
Antioxidant Status During Burn Rehabilitation
June 15, 2013 updated by: Michele Gottschlich, Shriners Hospitals for Children
Prospective Assessment of Antioxidant Status of Pediatric Patients During Burn Rehabilitation
It is believed that children with a prior history of significant burn injury continue to manifest low levels of antioxidants well into their convalescence.The purpose of this study is to examine malondialdehyde (an oxidative lipid marker) and vitamins E, C and beta carotene status in reconstructive burn patients.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
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
Ages Eligible for Study
3 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
pediatric burn
Description
Inclusion Criteria:
- Greater than 3 but less than 19 years
- Reconstructive or followup outpatient care at least 1 year postburn
- Initial burn size > 40%
- Written informed consent and HIPAA authorization
Exclusion Criteria:
- History of multivitamin or steroid use, liver disease, preburn malnutrition
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
serum antioxidant levels
Time Frame: > 2 years postburn
|
> 2 years postburn
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michele M Gottschlich, Shriners Hospital 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
June 1, 2013
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
September 27, 2007
First Submitted That Met QC Criteria
September 27, 2007
First Posted (Estimate)
September 28, 2007
Study Record Updates
Last Update Posted (Estimate)
June 18, 2013
Last Update Submitted That Met QC Criteria
June 15, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-06-04-01
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.
Clinical Trials on Burns
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruiting
-
American Scitech InternationalJohnson & JohnsonUnknownBurns | Electric BurnsUnited States
-
MediWound LtdUnknownBurns, Upper Extremity | Burns, Lower ExtremitySlovakia
-
Singapore General HospitalUnknownAcute Thermal BurnsSingapore
-
RenovaCare, IncActive, not recruitingBurns | Burns Second Degree | Burns Deep Second DegreeUnited States
-
Sun Yat-sen UniversityCompleted
-
Hennepin Healthcare Research InstituteNot yet recruiting
-
Buckinghamshire Healthcare NHS TrustNot yet recruitingBurns Multiple
-
Virginia Commonwealth UniversityWithdrawn
-
Riphah International UniversityActive, not recruiting