BurnsNCT00536822
Antioxidant Status During Burn Rehabilitation
An observational study of Burns, run by Shriners Hospitals for Children.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 19 years
- Conditions the study is for
- Burns
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric burn
Who may be able to join
- 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
Who cannot join
- History of multivitamin or steroid use, liver disease, preburn malnutrition
About this study
Official title: 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.
- Conditions
- Burns
- Keywords
- rehabilitation, pediatrics
- Medical subject headings
- Burns
What is being measured
The primary outcome is the main question the study is designed to answer.
serum antioxidant levels
Measured: > 2 years postburn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startJun 2013
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Study withdrawn due to hospital emphasis on funded studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Gottschlich, Shriners Hospitals for Children
- Investigators
- Michele M Gottschlich, Principal investigator, Shriners Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536822
- Sponsor's protocol ID
- 07-06-04-01
- Status last verified
- Jun 2013
- First submitted
- 27 Sep 2007
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Antioxidant Status of Pediatric Patients During Burn Rehabilitation
- ClinicalTrials.gov ID
- NCT00536822
- Acronym / sponsor ID
- 07-06-04-01
- Conditions
- Burns
- Keywords
- rehabilitation, pediatrics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to hospital emphasis on funded studies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric burn
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- History of multivitamin or steroid use, liver disease, preburn malnutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum antioxidant levels
Time frame: > 2 years postburn
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele M Gottschlich principal investigator
Shriners Hospital for Children
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by Shriners Hospitals for Children.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum antioxidant levels (time frame: > 2 years postburn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.