NCT00536822

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2013

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2007

Completed
5.7 years until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

Same day

First QC Date

September 27, 2007

Last Update Submit

June 15, 2013

Conditions

Keywords

rehabilitationpediatrics

Outcome Measures

Primary Outcomes (1)

  • serum antioxidant levels

    > 2 years postburn

Eligibility Criteria

Age3 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric burn

You may qualify if:

  • 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

You may not qualify if:

  • History of multivitamin or steroid use, liver disease, preburn malnutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: NONE RETAINED

No specimens.

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Michele M Gottschlich

    Shriners Hospital for Children

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

September 27, 2007

First Posted

September 28, 2007

Study Start

June 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 18, 2013

Record last verified: 2013-06