Text Size

Antioxidant Status During Burn Rehabilitation

This study is not yet open for participant recruitment.
Verified December 2012 by Shriners Hospitals for Children
Sponsor:
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00536822
First received: September 27, 2007
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Burns

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Assessment of Antioxidant Status of Pediatric Patients During Burn Rehabilitation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • serum antioxidant levels [ Time Frame: > 2 years postburn ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

No specimens.


Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

pediatric burn

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536822

Contacts
Contact: Michele M Gottschlich, PhD, RD, CNSD 513-872-6298 mgottschlich@shrinenet.org
Contact: Theresa Mayes, BS, RD 513-872-6043 tmayes@shrinenet.org

Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Principal Investigator: Michele M Gottschlich Shriners Hospital for Children
  More Information

No publications provided

Responsible Party: Michele Gottschlich, Research Scientist, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00536822     History of Changes
Other Study ID Numbers: 07-06-04-01
Study First Received: September 27, 2007
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
rehabilitation
pediatrics

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013